Company:Toshiba America Medical Systems, Inc., Date of Enforcement Report:12/5/2007 Class:ll PRODUCT Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008 REASON System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.. RECALLING FIRM/MANUFACTURER Recalling Firm: Toshiba America Medical...Read More

Company:Siemens Medical Solutions USA, Inc., Date of Enforcement Report:12/5/2007 Class:ll PRODUCT a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner, Recall # Z-0269-2008; b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Recall # Z-0270-2008; c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Recall # Z-0271-2008; d) Siemens ECAT EXACT HR 47, Catalog...Read More

Company:Misys Healthcare Systems Date of Enforcement Report:12.5/2007 Class:ll PRODUCT Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2, Recall # B-0317-08 REASON Software, with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, by e-mail on August 24, 2007. Firm initiated recall is ongoing. VOLUME...Read More

Company: Medtronic Navigation, Inc Date of Enforcement Report:12/5/2007 Class:ll PRODUCT Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008 REASON Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180′ on the StealthStation image. (If...Read More