GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
FDA device recall Z-0041-2007 · posted 2006-10-25 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
- Action taken
- Consignees will be notified by letter beginning 10/16/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 40 units
- Distribution
- FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France.
- Date initiated
- 2006-09-13
- Date posted
- 2006-10-25
- Date terminated
- 2009-08-13
- 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 |