The Cancer & Oncology Daily Alerts

Alerts

Siemens Medical Solutions USA, Inc - Siemens ARTISTE, ONCOR and PRIMUS systems. - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

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Date: 26 Apr 2013

Varian Medical Systems, Inc. Oncology Systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patient s respiratory motion information to synchronize their operation with the respiratory motion. (Source: Medical Device Recalls)

Date: 23 Apr 2013

GE Healthcare, LLC - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE Healthcare Infinia / Infinia vc Hawkey 4 and Infinia / Infinia vc . Recall includes all Infinia systems, all configurations. Product Usage: K022960 The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT , Gated SPECT , Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak ...

Date: 10 Apr 2013

Siemens Medical Solutions USA, Inc - ELEKTA MOSAIQ SW - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 10 Apr 2013

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 02 Apr 2013

Elekta, Inc. - Apex Addon microMLC - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Apex It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues. (Source: Medical Device Recalls)

Date: 26 Feb 2013

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore and Brilliance Big Bore Oncology CT XRay Scanners - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260, 510(k) #K012009. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, as well as patient and equipment supports, components and accessories. (Source: Medical Device Recalls)

Date: 26 Feb 2013

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Varian Eclipse" Treatment Planning System for Radiotherapy; Model Number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)

Date: 20 Feb 2013

Winco Mfg., LLC - Cozy Comfort Premier Recliner 5580 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Cozy Comfort Premier Recliner 5580 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. (Source: Medical Device Recalls)

Date: 04 Feb 2013

Winco Mfg., LLC - PREMIER LIFECARE RECLINER 5400 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

PREMIER LIFECARE RECLINER 5400 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. (Source: Medical Device Recalls)

Date: 04 Feb 2013

Winco Mfg., LLC - PREMIER CARE RECLINER 5570/5574 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

PREMIER CARE RECLINER 5570/5574 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. (Source: Medical Device Recalls)

Date: 04 Feb 2013

Winco Mfg., LLC - Designer Care Cliner 6700/6704/6710 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Designer Care Cliner 6700/6704/6710 The products are a multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. (Source: Medical Device Recalls)

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Date: 04 Feb 2013

Varian Medical Systems, Inc. - Segmented Cervix Applicator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy. (Source: Medical Device Recalls)

Date: 20 Dec 2012

Varian Medical Systems, Inc. Oncology Systems - Varian brand ARIA Radiation Oncology - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA (Source: Medical Device Recalls)

Date: 17 Dec 2012

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare BR Assay for CA 27.29 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. (Source: Medical Device Recalls)

Date: 11 Dec 2012

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur CA 199 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. (Source: Medical Device Recalls)

Date: 11 Dec 2012

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with a bronchoscope. They are used to puncture the tracheobronchial wall and to aspirate sufficient tissue and/or cell specimens to stage bronchogenic carcinoma. These are disposable sterile, single-use devices. (Source: Medical Device Recalls)

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Date: 10 Dec 2012

Philips Medical Systems (Cleveland), Inc. - Pinnacle3 Radiation Therapy Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this syste...

Date: 05 Nov 2012

Varian Medical Systems, Inc. Oncology Systems - ARIA Radiation Oncology Version 11 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. (Source: Medical Device Recalls)

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Date: 01 Nov 2012

Elekta, Inc. - Oncology Information System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images. (Source: Medical Device Recalls)

Date: 30 Oct 2012

Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur BR Assay - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended ...

Date: 28 Oct 2012

GE Healthcare, LLC - GE Discovery NM/CT670; GE Discovery NM 630 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported b...

Date: 23 Oct 2012

Elekta, Inc. - Oncentra External Beam - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. (Source: Medical Device Recalls)

Date: 23 Oct 2012

Varian Medical Systems, Inc. Oncology Systems - Varian brand Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes. (Source: Medical Device Recalls)

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Date: 26 Sep 2012

Varian Medical Systems, Inc. Oncology Systems - Varian brand Clinac, Trilogy, Novalis Tx Unique, linear accelerators - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 14 Sep 2012

Toshiba American Medical Systems Inc - Scanner, Computed Tomography, XRay - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstruction!;, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. This device employs no inten...

Date: 24 Aug 2012

Galil Medical, Inc. - VisualICE Cryoablation System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures. (Source: Medical Device Recalls)

Date: 23 Aug 2012

Philips Medical Systems (Cleveland) Inc - Positron Emission Tomography (PET) and Xray Computed Tomography - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing an...

Date: 22 Aug 2012

Varian Medical Systems, Inc. Oncology Systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information. (Source: Medical D...

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Date: 08 Aug 2012

Roche Molecular Systems, Inc. - cobas KRAS Mutation Test - Class 3 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The cobas KRAS Mutation Test, for use with the cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC). (Source: Medical Device Recalls)

Date: 08 Aug 2012

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is th...

Date: 26 Jul 2012

Siemens Medical Solutions USA, Inc - ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 24 Jul 2012

Philips Medical Systems (Cleveland) Inc - Brilliance CT 6slice,16slice, 40channel, 64channel,Big Bore Oncology & Brilliance iCT and iCT SP - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes (Source: Medical Device Recalls)

Date: 19 Jul 2012

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)

Date: 19 Jul 2012

Impac Medical Systems Inc - MOSAIQ Oncology Information Systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086 (Source: Medical Device Recalls)

Date: 06 Jul 2012

Abbott Laboratories - ARCHITECT CA 199XR Reagent Kit - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 2K91-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods. (Source: Medical Device Recalls)

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Date: 29 Jun 2012

Computerized Medical Systems Inc - XiO Radiation Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. (Source: Medical Device Recalls)

Date: 22 May 2012

Beckman Coulter Inc. - Access Hybritech Free PSA - Class 3 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL. (Source: Medical Device Recalls)

Date: 22 May 2012

Varian Medical Systems, Inc. Oncology Systems - TrueBeam and TrueBeam STx - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Varian Medical Systems, Palo Alto, CA. (Source: Medical Device Recalls)

Date: 16 May 2012

Cordis Corporation - Transhepatic Biliary Stent System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" Catalog C06120MB Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698. Catalog C06150MB Lot No's. 15530115, 15536150, 15556366, 15560543. Catalog C07120 MB Lot No's. 15530114, 15556368, 15560545, 15562701. Catalog C07150MB Lot No's. 15530113, 15556371, 15560546. Catalog C08120MB Lot No's. 15530112. Catalog C08150MB Lot No's. 15535365...

Date: 10 May 2012

Siemens Medical Solutions USA, Inc - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; ARTISTE/ONCOR/PRIMUS systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 Product Usage: Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 08 May 2012

Varian Medical Systems, Inc. Oncology Systems - True Beam - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical Systems, Palo Alto, CA. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 08 May 2012

Siemens Medical Solutions USA, Inc - ARTISTE or ONCOR Linear Accelerators in combination with 160MLC - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: ARTISTE MV System; ONCOR Avant Garde ONCOR Impression ONCOR Impression Plus ONCOR Expression. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; Registered by Siemens Medical Solutions, Concord, CA. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Product Model with Part Number: ARTISTE MV System, 8139789; ONCOR Avant Garde, 5863472; ONCOR Impression, 5857920; ONCOR Impression, Plus 5857912; ONCOR Expression, 7360204; ONCOR Expression, 7360717. ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation ...

Date: 07 May 2012

Siemens Medical Solutions USA, Inc - ARTISTE, ONCOR and PRIMUS Linear Accelerator systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478. Product Usage: The intended use of the SIEMENS branded ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 03 May 2012

Winco Mfg., LLC - Care Cliner - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE CLINER 6940/6950***Winco***ISO 9001-2008 Certified***Hassle-free design to optimize your patients comfort***This Elite Care Cliner features dual swing-arms, allowing patients with limited mobility a modified entry. Also, LiquiCell has been added into the seat for extra comfort. This ultra-thin, liquid-filled interface aids in improved blood flow, and helps prevent skin breakdown.***HEAT MASSAGE(Optional)***KEY FEATURES***Dual side swing-arms for modified entry and ease of cleaning***Dual fold down tables***LiquiCell for added comfort***5" nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***&quo...

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Date: 25 Apr 2012

Philips Medical Systems (Cleveland) Inc - GEMINI GXL 6, 10 & 16 Computed Tomography XRay Systems, - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at differ...

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Date: 05 Apr 2012

Philips Medical Systems (Cleveland) Inc - Extended Brilliance Workstation Computed Tomography XRay Systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Extended Brilliance Workstation Computed Tomography X-Ray Systems, M/N 728260, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Tra...

Date: 05 Apr 2012

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore Computed Tomography XRay Systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained ...

Date: 05 Apr 2012

Philips Medical Systems (Cleveland) Inc - GEMINI TF 16, 64 & Big Bore Computed Tomography XRay Systems - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at ...

Date: 05 Apr 2012

Medtronic Neuromodulation - Medtronic, Model 8870, Application Software Card - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Medtronic, Model 8870, Application Software Card is part of the SynchroMed¿ II Drug Infusion System. The System includes the SynchroMed¿ II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): ¿ The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. ¿ The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection)...

Date: 30 Mar 2012

Siemens Medical Solutions USA, Inc - MOSAIQ System; - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P (Source: Medical Device Recalls)

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Date: 21 Mar 2012

Varian Medical Systems, Inc. Oncology Systems - FastPlan Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software. (Source: Medical Device Recalls)

Date: 16 Mar 2012

Idev Technologies, Inc. - Stent Delivery Catheter - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. (Source: Medical Device Recalls)

Date: 15 Mar 2012

Siemens Medical Solutions USA, Inc - Siemens mMLC (ModuLeaf) - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue. (Source: Medical Device Recalls)

Date: 07 Mar 2012

Siemens Healthcare Diagnostics, Inc - ADVIA Centaur Intact PTH (iPTH) Assay - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy. (Source: Medical Device Recalls)

Date: 07 Mar 2012

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Eclipse Treatment Planning System, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0; Model H48 Varian Medical Systems, Palo Alto, CA. Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)

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Date: 06 Mar 2012

Varian Medical Systems, Inc. Oncology Systems - TrueBeam Radiotherapy Delivery System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 06 Mar 2012

GE Healthcare, LLC - GE Discovery NM 630 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and im...

Date: 27 Feb 2012

GE Healthcare, LLC - GE Discovery NM/CT 670 - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported ...

Date: 27 Feb 2012

Siemens Medical Solutions USA, Inc - Syngo RT - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 23 Feb 2012

Varian Medical Systems, Inc. Oncology Systems - 52leaf Millennium MLC multileaf collimator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. (Source: Medical Device Recalls)

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Date: 23 Feb 2012

Varian Medical Systems, Inc. Oncology Systems - 52leaf Standard MLC multileaf collimator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. (Source: Medical Device Recalls)

Date: 23 Feb 2012

GE Healthcare, LLC - GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems. (Source: Medical Device Recalls)

Date: 20 Feb 2012

Cordis Corporation - S.M.A.R.T. CONTROL Transhepatic Biliary Stent - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T¿ CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516. (Source: Medical Device Recalls)

Date: 15 Feb 2012

Cordis Corporation - S.M.A.R.T. CONTROL and PRECISE RX Transhepatic Biliary Stent - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

S.M.A.R.T. CONTROL Transhepatic Biliary Stent and PRECISE RX Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stents are delivered by catheter for the palliation of malignant neoplasms in the biliary tree. Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150 . The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T¿ CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516. (Source: Medical Device Recalls)

Date: 15 Feb 2012

Cincinnati Sub-Zero Products Inc - HyperHypothermia System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Blanketrol II 48¿C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48¿C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the...

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Date: 07 Feb 2012

Varian Medical Systems, Inc. Oncology Systems - Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from ex...

Date: 03 Feb 2012

Philips Medical Systems (Cleveland) Inc - Philips Medical Systems GEMINI TF 16 PET/CT System &38; GEMINI TF 64 PET/CT System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, disp...

Date: 02 Feb 2012

Stryker Howmedica Osteonics Corp. - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Duration¿ packaging distributed by Stryker¿ Orthopaedics, Limerick, Ireland Stryker¿ Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Product Usage: Orthopaedic implants utilized for primary and revision hip and knee (total and unilateral); total shoulder and elbow replacement; replacement; and oncological surgical procedures related to tumor resection. All devices are manufactured from UHMWPE and are processed through post-sterilization (gamma irradiation) heat treatment for stabilization (i.e. Duration¿¿ process). Launched in 1996, Duration¿¿ Stabilized Polyethylene is produced by a patented process utilizing a combination of nitrogen packaging to reduce shelf oxidation, gamma irradiation (3Mrads) to sterilize and crosslink th...

Date: 30 Jan 2012

FDA OKs Axitinib for Kidney Cancer Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

(MedPage Today) -- Another angiogenesis blocker, axitinib (Inlyta), has won FDA approval as a second-line treatment for advanced kidney cancer, the agency said Friday. (Source: MedPage Today Product Alert)

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Date: 27 Jan 2012

Siemens Medical Solutions USA, Inc - MEVATRON - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Mevatron M2/PRIMUS Mid; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 17 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - Varian brand Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0; Model Number: H48; Reference/FSCA Identifier: CP-07007, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)

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Date: 13 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - Portal Vision (Electronic Portal Image Device) RArm with 4D Integrated Treatment Console - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Portal Vision, R-Arm with 4D Integrated Treatment Console; Varian Medical Systems. Palo Alto, CA. The Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Philips Medical Systems (Cleveland), Inc. - Pinnacle3 Radiation Therapy Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Pinnacle3 Radiation Therapy Planning System, software version 9.0. Model # Description 453560446041 Pinnacle3 version 9.0 English 453560446051 Pinnacle3 version 9.0 Simplified Chinese 453560446061 Pinnacle3 version 9.0 Traditional Chinese 453560446091 Pinnacle3 version 9.0 Dutch 453560446101 Pinnacle3 version 9.0 French 453560446111 Pinnacle3 version 9.0 German 453560446141 Pinnacle3 version 9.0 Italian 453560446161 Pinnacle3 version 9.0 Japanese 453560446181 Pinnacle3 version 9.0 Spanish 453560446201 Pinnacle3 version 9.0 Turkish Intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - Barcode Conical Collimator Verification (BCCV) - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB, distributed by and/or manufactured by: Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conic...

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - 4D Integrated Treatment Console (4DITC) - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873, Model Number: H51, distributed by and manufactured by: Varian Medical Systems Inc., Palo Alto, CA The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Col...

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - ARIA Radiation Oncology - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department s clinical and business information. (Source: Medical Device Reca...

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Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - Varian Unique Single Energy Linear Accelerator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - Varian brand High Energy Linear Accelerator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Siemens Medical Solutions USA, Inc - Siemens ARTISTE and ONCOR linear accelerator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Siemens Healthcare Diagnostics, Inc - ADVIA Centaur CA199 Assay - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (04612750) - 50 Test kit w/o Calibrators 10491244 - 250 Test kit w/Calibrators 10491379 - 50 Test kit w/Calibrators The ADVIA Centaur CA 19-9 Assay is an¿ in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined f...

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)

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Date: 11 Jan 2012

Siemens Medical Solutions USA, Inc - syngo RT Therapist and syngo RT Therapist - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update, the Oncologist will match the RTT version 4.2.108. The intended use of the Siemens branded Artiste, Oncor and Primus family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Life Technologies Corporation - SPOTLight HER2 CISH Kit - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

SPOT-Light" HER2 CISH¿ Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin¿ (trastuzumab) treatment is being considered. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator Varian Medical Systems, Palo Alto, CA. The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment.. The True Beam is a medical linear accelerator which delivers X-ray and electron radiation for sterotactic radiosurgery and therapeutic radiation. (Source: Medical Device Recalls)

Date: 11 Jan 2012

Heritage Labs International LLC - Heritage Labs St. Jude Childhood Cancer Study kit - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and blood specimen collection supplies. Blood specimen collection (Source: Medical Device Recalls)

Date: 11 Jan 2012

Varian Medical Systems, Inc. Oncology Systems - TrueBeam and TrueBeam STx, - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

TrueBeam and TrueBeam STx, Model Number: H19, Ref/FSCA identifier: CP-06381 are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. (Source: Medical Device Recalls)

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Date: 02 Dec 2011

Varian Medical Systems, Inc. Oncology Systems - Head Ring Posts; of the Optical Guidance Platform and Floorstand devices - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices. Varian Medical Systems, Palo Alto, CA 94304. The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions. (Source: Medical Device Recalls)

Date: 01 Dec 2011

Varian Medical Systems, Inc. Oncology Systems - GammaMed 12i Accessory - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 1-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, Bergische Strasse 16, D-42781 Haan, Germany. The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device. (Source: M...

Date: 01 Dec 2011

Varian Medical Systems, Inc. - Brachytherapy System, Remote Afterloader - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment. (Source: Medical Device Recalls)

Date: 01 Dec 2011

Varian Medical Systems, Inc. - GammaMed Flexible Applicator Probe - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA, Mfg. by Varian Medical Systems, Haan GmbH. Designed for brachytherapy intracavity treatments in areas such as cancer of the vagina, vaginal stump or rectum. (Source: Medical Device Recalls)

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Date: 30 Nov 2011

Elekta, Inc. - Medical linear acelerator (with patient imaging) - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)

Date: 29 Nov 2011

Medi-Physics Inc. dba GE Healthcare - Rapid Strand Rx - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. RAPID Strand Rx i...

Date: 22 Nov 2011

Medical Device Technologies, Inc. - Custom Bone Marrow Tray - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 2 - Towel; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0202TL***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. G...

Date: 18 Nov 2011

Varian Medical Systems, Inc. Oncology Systems - Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Manufactured by Varian Medical System, Palo Alto, CA. Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 09 Nov 2011

Becton Dickinson & Company - BD Microtainer MAP Microtube for Automated Process. - Class 3 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients. (Source: Medical Device Recalls)

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Date: 08 Nov 2011

FDA OKs Cetuximab for Advanced Head and Neck Cancer Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

(MedPage Today) -- The monoclonal antibody cetuximab (Erbitux) is now approved for treatment of late-stage head and neck cancers in combination with chemotherapy, the FDA announced. (Source: MedPage Today Product Alert)

Date: 08 Nov 2011

GE Healthcare, LLC - GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer. (Source: Medical Device Recalls)

Date: 26 Oct 2011

GE Healthcare, LLC - GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The Senographe DS is intended to be used in the same clinical applications as traditional mammographic film/screen systems. (Source: Medical Device Recalls)

Date: 26 Oct 2011

Varian Medical Systems, Inc. Oncology Systems - 4D Integrated Treatment Console - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3; Varian Medical Systems, Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. (Source: Medical Device Recalls)

Date: 14 Sep 2011

Varian Medical Systems, Inc. Oncology Systems - Varian Treatment - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian Treatment version 6.6.5052. Varian Medical Systems, Palo Alto, Ca Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan. (Source: Medical Device Recalls)

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Date: 31 Aug 2011

Varian Medical Systems, Inc. Oncology Systems - 4D INTEGRATED TREATMENT CONSOLE - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, version 8.1 SP2 to 10.0 SP1; Model Number: H51; Reference/PSCA Identifier: CP-03940; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. (Source: Medical Device Recalls)

Date: 31 Aug 2011

Varian Medical Systems, Inc. Oncology Systems - OnBoard Imager (OBI); Trilogy Mx - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields relation to anatomical and/or fiducial landmarks. Trilogy Mx is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. (Source: Medical Device Recalls)

Date: 31 Aug 2011

Varian Medical Systems, Inc. - BrachyVision Software, part of Eclipse TPS - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way, Palo Alto, California 94304-1038. Used to plan radiotherapy treatments for patients with malignant or benign diseases. In addition, the module is specifically indicated for planning proton treatment of neoplasms of the eye. (Source: Medical Device Recalls)

Date: 31 Aug 2011

Varian Medical Systems, Inc. Oncology Systems - 4D Integrated Treatment Console (4DITC) - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Varian brand 4D Integrated Treatment Console (4DITC) Radiation Therapy, Interpretation of a RapidArc Treatment Plan as a 3D Conformal Arc Treatment Plan; version v8.6 or 8.8 in combination with treatment planning systems; Model Number: H51; Reference/PSCA Identifier: CP-03063; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: 4D Integrated treatment console is designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. (Source: Medical Device Recalls)

Date: 30 Aug 2011

Elekta, Inc. - The Elekta Synergy System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. (Source: Medical Device Recalls)

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Date: 29 Aug 2011

Non-Small Cell Lung Cancer Drug Gets FDA Nod Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

WASHINGTON (MedPage Today) -- The FDA has approved crizotinib (Xalkori), a novel targeted therapy for late-stage non-small cell lung cancer. (Source: MedPage Today Product Alert)

Date: 27 Aug 2011

Varian Medical Systems, Inc. Oncology Systems - HighDefinition 120 Multileaf Collimator (HD120 MLC) - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. (Source: Medical Device Recalls)

Date: 22 Aug 2011

Varian Medical Systems, Inc. Oncology Systems - Flexible Probe with Blocking Washer - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum. (Source: Medical Device Recalls)

Date: 22 Aug 2011

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall Share on Facebook. Tweet this article. Share on Google Plus. Save to Delicious. Post to StumbleUpon. Digg this.

Eclipse Treatment Planning System, 4D Structure Merge Tool Option in Eclipse Release 8.5 -10 (Client Build 8.2.2x through 10.0.34) with 4D Planning; Model Number: H48; Reference/FSCA Identifier: CP-04931; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. (Source: Medical Device Recalls)

Date: 15 Aug 2011