Company:Philips Medical Systems NederlandsDate of Enforcement Report 3/28/12 Class lll: PRODUCT 1) Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. Recall # Z-1196-2012;...Read More

Company:CareFusion 209 Inc. Date of Enforcement Report 3/28/12 Class l: PRODUCT 1) NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing...Read More

Company:Roche Diagnostics Operations, Inc. Date of Enforcement Report 3/28/12 Class ll: PRODUCT LElecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids. a) Elecsys 2010 Analyzer Rack; b) Elecsys 2010 Analyzer Disk; c) Software version 06-07. Recall # Z-1218-2012 REASON...Read More