Company:GE Medical Systems, LLCDate of Enforcement Report 8/26/2009 Class:ll PRODUCT GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images, Recall # Z-1720-2009 REASON...Read More

Company:Veridex, LLCDate of Enforcement Report 8/26/2009 Class:ll PRODUCT CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater, Recall # Z-1734-2009 REASON Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System. RECALLING FIRM/MANUFACTURER Veridex, LLC, Raritan, NJ, by letter dated March 12,...Read More

Company: Cardinal HealthDate of Enforcement Report 8/26/2009 Class:l PRODUCT 1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009; 2) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the...Read More