Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Siemens Somatom CT’s equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. Recall Number Z-0948-2013 REASON Sporadic hang-up malfunctions concerning 3D reconstructions during activated “Preview Image” functionality RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. Z-0935-2013 REASON An error on the SR Viewer Reporting Tool...Read More

Company:Philips Medical Systems Inc. Date of Enforcement Report 3/20/2013 Class ll: PRODUCT Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This...Read More