OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic a
FDA device recall Z-2026-2012 · posted 2012-07-18 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
- Action taken
- Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE Healthcare sent an"URGENT RECALL NOTICE" dated February 22, 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 800-874-7378 for questions concerning this recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 11,100 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2007-11-19
- Date posted
- 2012-07-18
- Date terminated
- 2013-01-28
- 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 |
| OEC FLUOROTRAK 9800 PLUS (K022069) | Ge Oec Medical Systems | 2002-09-17 |
| OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049) | Ge Oec Medical Systems | 2002-04-17 |