Recall Z-1993-2012 ยท IZL System, X-Ray, Mobile
GE Healthcare, LLC
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
| Date | Jul 19, 2012 (initiated Apr 4, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3. |
| 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 to the user or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the firmware on the system to address the issue. Your proposed corrective action plan (CAP) (Field Modification Instructions 10865) describes the rework plan that GEHC Engineers will mak |
| Quantity | 254 units have been shipped to/installed in the U.S. |
| Distribution | Worldwide Distribution (USA) nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.