GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA device recall Z-0716-2008 · posted 2008-03-15 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.
- Action taken
- On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 157 units (Domestic), 142 units (Foreign)
- Distribution
- Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark,
- Date initiated
- 2007-09-28
- Date posted
- 2008-03-15
- Date terminated
- 2011-11-01
- 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
| Record | Firm | Date |
|---|---|---|
| SERIES 7600 MOBILE DIGITAL C-ARM (K970063) | Ge Dec Medical Systems | 1997-03-11 |