OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,
FDA device recall Z-0559-2007 · posted 2007-03-22 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- During routine service, a cover may have been installed without the required proper lead shielding.
- Action taken
- Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 11 units of all models
- Distribution
- Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
- Date initiated
- 2007-02-09
- Date posted
- 2007-03-22
- Date terminated
- 2007-06-26
- 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 |