Company:Siemens Medical Solutions Date of Enforcement Report:4/6/2007 Class:ll PRODUCT Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system, Recall # Z-0652-2007 REASON The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due...Read More

Company:GE OEC Medical Systems,Inc Date of Enforcement Report:4/6/2007 Class:ll PRODUCT InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body), Recall # Z-0704-2007 REASON Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software. CODE InstaTrak 3500 Plus...Read More

Company:Boston Scientific Corp. Date of Enforcement Report:4/6/2007 Class:ll PRODUCT a) Product Description: HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall # Z-0687-2007; b) HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system), Recall #...Read More