OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OE
FDA device recall Z-1705-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- Use of existing four-pedal footswitch on a different machine may cause various operational errors.
- Action taken
- Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 78 units
- Distribution
- Nationwide, including one VA facility in FL. No military or foreign distribution.
- Date initiated
- 2008-04-15
- Date posted
- 2008-09-01
- Date terminated
- 2011-12-21
- 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 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012) | Ge Oec Medical Systems | 2003-03-20 |
| OEC FLUOROTRAK 9800 PLUS (K022069) | Ge Oec Medical Systems | 2002-09-17 |
| OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049) | Ge Oec Medical Systems | 2002-04-17 |