Recall Z-0450-2013 ยท IZL System, X-Ray, Mobile
GE Healthcare, LLC
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for d
| Date | Nov 29, 2012 (initiated Aug 1, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare will without charge remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication through a GE Healthcare field engineer site visit. Field Modification Instructions (FMI) 10868 describes the rework plan the GEHC Engineers will make to the imaging system compliant with the applicable performance standard. This CAP appears to adequately address the problem and is hereby approved. Call C |
| Quantity | 217 total installed in the US |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.