Advantx 1 LC1 Model 45258230 Angiographic X-ray System
FDA device recall Z-0897-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Distribution
- The units were distributed nationwide in the United States and worldwide.
- Date initiated
- 2004-03-24
- Date posted
- 2004-07-20
- Date terminated
- 2006-07-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LC, CARDIAC POSITIONER #B5078A (K890348) | General Electric Co. | 1989-02-27 |