Company: Siemens Medical Solutions, USA, IncDate of Enforcement Report:7/26/2006 Class:lIl PRODUCTKinetDx 4.0 Ultrasound Image Management System, Recall # Z-1235-06 REASON The cardiologist’s report comments may not be retained by the system due to a software bug.. CODE All units with software versions 4.0 and 4.1 RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Solutions, USA, Inc., Ann...Read More

Company: Beckman Coulter, Inc., Date of Enforcement Report:7/26/2006 Class:lI PRODUCT Coulter LH500 Hematology Analyzer; Part Numbers 178832, 178833 and 178834, Recall # Z-1245-06 REASON Beckman has confirmed that erroneous results could be reported when the workstation data base crashes. CODE All software versions RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter sent...Read More