OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
FDA device recall Z-0683-2007 · posted 2007-09-28 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Action taken
- Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 1
- Distribution
- Nationwide and Germany.
- Date initiated
- 2007-03-01
- Date posted
- 2007-09-28
- Date terminated
- 2012-05-01
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM (K041932) | Ge Oec Medical Systems, Inc. | 2004-08-18 |