Recall Z-2256-2012 ยท IZL System, X-Ray, Mobile
GE Healthcare, LLC
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
| Date | Sep 13, 2012 (initiated Jul 10, 2012) |
| Status | Terminated |
| Reason | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue. Field Modification Instructions (FMI) 10865(2) describes the rework plan the GEHC Engineers will |
| Quantity | 254 total in the US |
| Distribution | Worldwide Distribution -- USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.