Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use. Recall Number Z-1735-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use. Recall Number Z-1736-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. Recall Number Z-1734-2014 REASON Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/18/2014 Class lI: PRODUCT Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. Recall Number Z-1783-2014 REASON If a customer creates customized trend scales in the trend review tile and the iX or...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 6/18/2014 Class lI: PRODUCT IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 Recall Number Z-1746-2014 REASON IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms...Read More

Company: Mckesson Medical Immaging.Date of Enforcement Report:6/18/2014 Class lI: PRODUCT Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-1728-2014 REASON...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation System Configured with TCAutomation” Software v3.5 — For in vitro quantitative measurement of a variety of analytes of clinical interest — The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report:6/18/2014 Class lI: PRODUCT enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) — For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes...Read More