Recall Z-0198-2013 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE Healthcare, LLC
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
| Date | Nov 16, 2012 (initiated Sep 20, 2012) |
| Status | Terminated |
| Reason | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122. |
| Quantity | 364 total units installed in 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.