Company: Varian MedicalDate of Enforcement Report 12/1/2010 Class ll: PRODUCT Varian brand TrueBeam and TrueBeam STx, Model Number: TMX- H19. Recall # Z-0106-2011 REASON Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects “Apply Shift” and presses Motion Enable buttons. This can result in the...Read More

Company: Medtronic Inc.Date of Enforcement Report 12/1/2010 Class ll: PRODUCT 1) Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene oxide. The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that...Read More

Company: GE Healthcare ITDate of Enforcement Report 12/1/2010 Class ll: PRODUCT GE Centricity Laboratory Instrument Interface software. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-0123-2011 REASON Instrument...Read More

Company: Impac Medical Systems IncDate of Enforcement Report 12/1/2010 Class ll: PRODUCT Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine. Recall # Z-0159-2011 REASON Mistreatment–...Read More