Company: Toshiba America Medical Systems, Inc., Date of Enforcement Report:3/8/2006 Class:Il PRODUCT Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06 REASON Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use. CODE Serial numbers D4622390, D4622394, D4623349, D4612382,...Read More

Company: Nova Biomedical Corporation., Date of Enforcement Report:1/27/2006 Class:Ill PRODUCT a) Star Profile Critical Care (CCX) Analyzer Catalog Number: 35942, Recall # Z-0576-06; b) Star Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413, Recall # Z-0577-06; c) CCX Operating Software, Version 4.08, Recall # Z-0578-06 REASON Analyzers may fail to perform scheduled automatic two-point...Read More

Company: Fujifilm Medical System USA, Inc., Date of Enforcement Report:3/222006 Class:Il PRODUCT Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS, Recall # Z-0622-06 REASON Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.. CODE Versions 3.1.0 and 3.1.1 RECALLING...Read More

Company: Beckman Coulter, Inc., Date of Enforcement Report:3/8/2006 Class:lI PRODUCT UniCel Dxl 800 Access Immunoassay System, Recall # Z-0583-06 REASON The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances) CODESoftware Versions 2.2.1 and earlier RECALLING FIRM/MANUFACTURER...Read More