Company: Naviscan PET Systems Date of Enforcement Report:10/17/2007 Class:lll PRODUCT PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008 REASON Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired...Read More

Company: Medtronic Neurological, Date of Enforcement Report:10/17/2007 Class:ll PRODUCT Medtronic InterStim II INS Model 3058 with N’Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N’Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008 REASON A software issue may cause a lower than...Read More

Company: Beckman Coulter Incl, Date of Enforcement Report:10/24/2007 Class:ll PRODUCT FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008 REASON Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter...Read More