MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.
FDA device recall Z-0704-06 · posted 2006-09-30 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems,Inc
- Reason for recall
- Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
- Action taken
- Consignees were notified by letter prior to 04/28/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 534 units (Domestic), 125 (Intl)
- Distribution
- Nationwide.
- Date initiated
- 2006-03-28
- Date posted
- 2006-09-30
- Date terminated
- 2011-07-25
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINI 6800 DIGITAL MOBILE C-ARM (K992506) | Ge Dec Medical Systems | 1999-08-19 |