OEC 9900 Elite Image-intensified fluoroscopic x-ray system (includes OEC 9900 Elite Fluoroscopy System and 9900 EliteMD
FDA device recall Z-1706-2008 · 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
- 25 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
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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 |