Company: Beckman Coulter Inc. Date of Enforcement Report 8/29/12 Class ll: PRODUCT UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination...Read More

Company:Sunquest Information Systems, Inc. Date of Enforcement Report 8/29/12 Class lll: PRODUCT Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. Recall Number Z-2243-2012 REASON Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than...Read More

Company:achi Medical Systems America Inc Date of Enforcement Report 8/29/12 Class ll: PRODUCT Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. Z-2254-2012 REASON...Read More

Company:Baxter Healthcare Corp. Date of Enforcement Report 8/29/12 Class l: PRODUCT Product Name Product Codes Serial Numbers Automix High Speed Compounder System 2M8077 All Automix Plus High Speed Compounder System 2M8075 All Automix 3+3 Compounder System 2M8286 and 2M8286K All Automix 3+3 Compounder System with Accusource Monitoring System 2M8287 All Range of Manufacturing and Distribution...Read More

Company:AGFA Corp. . Date of Enforcement Report 8/29/12 Class ll: PRODUCT AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device .Recall Number Z-2252-2012 REASON Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa’s Medical...Read More