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Siemens Medical Solutions USA, Inc - Siemens ARTISTE, ONCOR and PRIMUS systems. - Class 2 Recall
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)
Source: Medical Device Recalls - April 26, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Class 2 Recall
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)
Source: Medical Device Recalls - April 23, 2013 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - Class 2 Recall
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 tom...
Source: Medical Device Recalls - April 10, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ELEKTA MOSAIQ SW - Class 2 Recall
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)
Source: Medical Device Recalls - April 10, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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 2.1, Part No. 8147667, Current R640; 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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 Impression TH, Part No. 7341410, 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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: Primeview 3i 2.1, Part No. 8147675, Current R640; 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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 2.2, Part No. 10568431, Current R640; 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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 2.0, Part No. 8139839, 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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: Primeview 3i 2.0, Part No. 8139847, 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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 AG TH, Part No. 5863506, 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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - COHERENCE RT Therapist - Class 2 Recall
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: Primeview 3i, Part No. 7341428, Current R610/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)
Source: Medical Device Recalls - April 2, 2013 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Apex Addon microMLC - Class 2 Recall
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)
Source: Medical Device Recalls - February 26, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore and Brilliance Big Bore Oncology CT XRay Scanners - Class 2 Recall
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)
Source: Medical Device Recalls - February 26, 2013 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore and Brilliance Big Bore Oncology CT XRay Scanners - Class 2 Recall
Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244, 510(k) #K033357. The Brilliance CT Big Bore is a Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include display equipment, signal analysis, as well as patient and equipment supports, components and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 26, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall
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)
Source: Medical Device Recalls - February 20, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - Cozy Comfort Premier Recliner 5580 - Class 2 Recall
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)
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - PREMIER LIFECARE RECLINER 5400 - Class 2 Recall
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)
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - PREMIER CARE RECLINER 5570/5574 - Class 2 Recall
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)
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Winco Mfg., LLC - Designer Care Cliner 6700/6704/6710 - Class 2 Recall
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)
Source: Medical Device Recalls - February 4, 2013 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Segmented Cervix Applicator - Class 2 Recall
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)
Source: Medical Device Recalls - December 20, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Varian brand ARIA Radiation Oncology - Class 2 Recall
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)
Source: Medical Device Recalls - December 17, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare BR Assay for CA 27.29 - Class 2 Recall
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)
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens Healthcare ADVIA Centaur CA 199 - Class 2 Recall
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)
Source: Medical Device Recalls - December 11, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
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)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 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)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 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)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

ConMed Corporation - WANG Transbronchial Aspiration Needles - Class 2 Recall
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral 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)
Source: Medical Device Recalls - December 10, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland), Inc. - Pinnacle3 Radiation Therapy Planning System - Class 2 Recall
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 ...
Source: Medical Device Recalls - November 5, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - ARIA Radiation Oncology Version 11 - Class 2 Recall
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)
Source: Medical Device Recalls - November 1, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Oncology Information System - Class 2 Recall
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)
Source: Medical Device Recalls - October 30, 2012 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur BR Assay - Class 2 Recall
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 ...
Source: Medical Device Recalls - October 28, 2012 Category: Medical Equipment Source Type: alerts

GE Healthcare, LLC - GE Discovery NM/CT670; GE Discovery NM 630 - Class 2 Recall
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 prod...
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

Elekta, Inc. - Oncentra External Beam - Class 2 Recall
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)
Source: Medical Device Recalls - October 23, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Varian brand Eclipse Treatment Planning System - Class 2 Recall
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 ...
Source: Medical Device Recalls - September 26, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Varian brand Clinac, Trilogy, Novalis Tx Unique, linear accelerators - Class 2 Recall
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)
Source: Medical Device Recalls - September 14, 2012 Category: Medical Equipment Source Type: alerts

Toshiba American Medical Systems Inc - Scanner, Computed Tomography, XRay - Class 2 Recall
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 metast...
Source: Medical Device Recalls - August 24, 2012 Category: Medical Equipment Source Type: alerts

Galil Medical, Inc. - VisualICE Cryoablation System - Class 2 Recall
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 lesion...
Source: Medical Device Recalls - August 23, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Positron Emission Tomography (PET) and Xray Computed Tomography - Class 2 Recall
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, he...
Source: Medical Device Recalls - August 22, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Class 2 Recall
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 provi...
Source: Medical Device Recalls - August 8, 2012 Category: Medical Equipment Source Type: alerts

Roche Molecular Systems, Inc. - cobas KRAS Mutation Test - Class 3 Recall
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)
Source: Medical Device Recalls - August 8, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
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-ca...
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Slide Processor. 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 the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. 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 the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Tripath Imaging, Inc. - PrepStain System - Class 2 Recall
PrepStain Kit: 1.2 DiTi Cone. 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 the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2012 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist - Class 2 Recall
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)
Source: Medical Device Recalls - July 24, 2012 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance CT 6slice,16slice, 40channel, 64channel,Big Bore Oncology & Brilliance iCT and iCT SP - Class 2 Recall
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)
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. Oncology Systems - Eclipse Treatment Planning System - Class 2 Recall
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)
Source: Medical Device Recalls - July 19, 2012 Category: Medical Equipment Source Type: alerts

Impac Medical Systems Inc - MOSAIQ Oncology Information Systems - Class 2 Recall
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)
Source: Medical Device Recalls - July 6, 2012 Category: Medical Equipment Source Type: alerts