Company:bioMerieux, Inc Date of Enforcement Report:7/11/2007 Class:ll PRODUCT a) Vitatron C-Series dual chamber Rate Responsive Pacemakers (C60DR) includes the following models: C60A1 and C60A3 for US distribution and C50A1, ..A2, A3, C60A2 for international distribution (the single chamber is not involved). C-series software is VSF11/VSF12 Version 1.0. Recall # Z-0999-2007; b) Vitatron T-Series Dual Chamber...Read More

Company:Brainlab AGDate of Enforcement Report:7/11/2007 Class:ll PRODUCT BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; catalog/version number 40700-3A, Recall # Z-1010-2007 REASON Target Alignment Error. A mechanical component/software incompatibility caused by a specific combination of the BrainLAB...Read More