Company:Toshiba American Med Sys Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Recall # Z-0771-2007 REASON Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature...Read More

Company:Instrumentation Laboratory Co., Lexington, MA, Date of Enforcement Report:5/9/2007 Class:ll PRODUCT GEM Premier 4000 Laboratory Analyzer, Recall # Z-0778-2007 REASON Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result. CODE Serial numbers prior to 07020343 with Software versions prior to V1.1.3 RECALLING FIRM/MANUFACTURER...Read More

Company:bioMerieux, Inc., Date of Enforcement Report:5/9/2007 Class:ll PRODUCT a) BacT/ALERT Classic System Software, Blood Culturing System, Recall # Z-0773-2007; b) BacT/ALERT 3D System Software, Blood Culturing System, Recall # Z-0774-2007; c) BacT/ALERT 3D Combo Systems Software, Blood Culturing System, Recall # Z-0775-2007; d) BacT/ALERT 3D 60 Systems Software, Blood Culturing System, Recall # Z-0776-2007 REASON...Read More