Company:GE Healthcare Date of Enforcement Report:8/21/2007 Class:ll PRODUCT a) GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE, Recall # Z-1132-2007; b) GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE, Recall # Z-1133-2007; c) GE Healthcare Systems ComboLab System. Made up...Read More

Company: Abbott LaboratoriesDate of Enforcement Report:8/22/2007 Class:ll PRODUCT a) CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, List Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Recall # Z-1170-2007 b) Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers...Read More