GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to pr
FDA device recall Z-0342-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- Under certain conditions, x-ray system may experience operational impairment.
- Action taken
- Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 448 units
- Distribution
- Nationwide, including AK, KY, NC, VA WA. and WI
- Date initiated
- 2008-08-29
- Date posted
- 2009-01-05
- Date terminated
- 2012-04-24
- 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
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| CYCLETRAC CT-5000 (K073542) | Pt Products, LLC | 2008-02-14 |