Company:Siemens Medical Solutions USA, IncDate of Enforcement Report 5/6/2009 Class:ll PRODUCT syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system. Recall # Z-1266-2009 REASON An issue concerning...Read More

Company:Cerner Corp.Date of Enforcement Report 5.6/2009 Class:ll PRODUCT Cerner Bridge Medical Transfusion Administration and Specimen Collections, Recall # Z-1236-2009 REASON Specimen labels printing incorrect patient demographics RECALLING FIRM/MANUFACTURER Cerner Corp, Kansas City, MO, by letter dated January 15, 2009. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 4 units DISTRIBUTION OH, NC, MO...Read More

Company:Cardinal Health Date of Enforcement Report 5/6/2009 Class:ll PRODUCT Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Recall # Z-1237-2009 REASON The Alaris PCA module can potentially infuse above or below the intended infusion dose. RECALLING FIRM/MANUFACTURER Cardinal Health 303...Read More