Company:Hamilton Medical Inc. Date of Enforcement Report 2/6/2013 Class l: PRODUCT HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics. Recall Number Z-0741-2013 REASON Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high...Read More

Company:GE Healthcare, LLC. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Recall Number Z-0754-2013 REASON It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image...Read More

Company:Envoy Medical Corp Date of Enforcement Report 2/6/2013 Class ll: PRODUCT Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer. Recall Number Z-0750-2013 REASON Envoy Medical is conducting a voluntary correction...Read More

Company:Roche Molecular Systems, Inc. Date of Enforcement Report 2/6/2013 Class ll: PRODUCT COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Recall Number Z-0762-2013 REASON The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test...Read More