GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
FDA device recall Z-0989-2007 · posted 2007-07-12 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
- Action taken
- Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 22 units
- Distribution
- Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
- Date initiated
- 2007-07-06
- Date posted
- 2007-07-12
- Date terminated
- 2013-02-01
- 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 |
|---|---|---|
| OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION (K041931) | Ge Oec Medical Systems, Inc. | 2004-08-26 |