Company: GE Healthcare LLC Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. Recall Number Z-0725-2014 REASON There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima...Read More

Company: GE Healthcare It Date of Enforcement Report: 1/22/2014 Class lI: PRODUCT Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review,...Read More

Company: Draeger Medical Systems, Inc. . Date of Enforcement Report:1/22/2014 Class lI: PRODUCT Draeger Infinity Acute Care System Monitoring Solution Recall Number Z-0714-2014 REASON After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate...Read More