GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
FDA device recall Z-0849-2007 · posted 2007-06-30 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- Action taken
- Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 131 units
- Distribution
- Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israe
- Date initiated
- 2007-06-12
- Date posted
- 2007-06-30
- Date terminated
- 2011-11-01
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012) | Ge Oec Medical Systems | 2003-03-20 |