GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc.
FDA device recall Z-1301-06 · posted 2006-09-30 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- X-ray systems could provide output which exceeds the 20 R/minute limit.
- Action taken
- Consignees were notified by certified letter on 08/14-15/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 202 units (US), 26 units (Foreign)
- Distribution
- Worldwide
- Date initiated
- 2006-08-16
- Date posted
- 2006-09-30
- Date terminated
- 2011-07-27
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION (K041931) | Ge Oec Medical Systems, Inc. | 2004-08-26 |