GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha
FDA device recall Z-1477-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Necessary certification labels are missing from the x-ray contol.
- Action taken
- A field Engineer from GE will visit the customer site to apply label to the X-ray control.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 437
- Distribution
- Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
- Date initiated
- 2007-08-13
- Date posted
- 2008-09-18
- Date terminated
- 2010-10-07
- 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 |