GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this devi
FDA device recall Z-1885-2008 · posted 2008-09-25 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- Beam limitation may be non-compliant on some X-ray units.
- Action taken
- Consignees were notified by letter on 08/12/2008. GE service representatives will check proper beam compliance on next scheduled maintenance visit or will schedule a visit to address the issue. Information available at 1-800-874-7378.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 335 systems
- Distribution
- Nationwide
- Date initiated
- 2008-08-12
- Date posted
- 2008-09-25
- Date terminated
- 2012-04-23
- 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 |