Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2016 Class lI: PRODUCT Cios Alpha, mobile X-ray system. Recall Number Z-1278-2016 REASON Software issues on Cios Alpha mobile C-Arm system RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc, Malvern, PA on 2/19/2016. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 89 systems DISTRIBUTION...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 4/6/2016 Class lI: PRODUCT Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 4/6/2016 Class lI: PRODUCT MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software 10805072 LabPro MBT Non-Connect Systems v4.30 10805073...Read More