Company: sanofi-aventis US, Inc.. Date of Enforcement Report 1/2/2013 Class ll: PRODUCT Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. Recall Number Z-0609-2013 REASON Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as...Read More

Company: Philips Medical Systems (Cleveland) Inc . Date of Enforcement Report 1/2/2013 Class ll: PRODUCT Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by...Read More

Company: Roche Molecular Systems, Inc. Date of Enforcement Report 1/2/2013 Class ll: PRODUCT COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland. Recall Number Z-0614-2013 REASON Certain COBAS AmpliPrep instruments...Read More