GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 24037
FDA device recall Z-1610-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I
- Action taken
- A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 2863 total (2744 US / 119 OUS)
- Distribution
- Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KU
- Date initiated
- 2008-01-02
- Date posted
- 2008-09-19
- Date terminated
- 2011-12-10
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |