Recall Z-0306-04 ยท IYB Tube Mount, X-Ray, Diagnostic
General Electric Med Systems
Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.
| Date | Jan 8, 2004 (initiated Dec 8, 2003) |
| Status | Terminated |
| Reason | Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall. |
| Root cause | Other |
| Action | Field Modification Instructions (FMI''s) will be issued to the field to inspect and locate suspect tubes and replace any that may be susceptible to failure. |
| Quantity | 400 |
| Distribution | Distributed nationwide throughout the US and worldwide. |
| FDA record | Open on fda.gov |