Recall Z-0896-04 ยท IZI System, X-Ray, Angiographic
General Electric Med Systems
Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System
| Date | Jul 20, 2004 (initiated Mar 24, 2004) |
| Status | Terminated |
| Reason | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
| Root cause | Other |
| Action | Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals. |
| Distribution | The units were distributed nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890348 | LC, CARDIAC POSITIONER #B5078A General Electric Co., Feb 27, 1989 |