GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188,
FDA device recall Z-1476-2008 · 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
- 448
- 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS (K051967) | GE Healthcare | 2005-08-09 |