Day

March 29, 2012
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;...
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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...
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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...
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