Recall Z-1476-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
| Date | Sep 18, 2008 (initiated Aug 13, 2007) |
| Status | Terminated |
| Reason | Necessary certification labels are missing from the x-ray contol. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A field Engineer from GE will visit the customer site to apply label to the X-ray control. |
| Quantity | 448 |
| Distribution | Worldwide including USA and countries of Italy, Japan, Spain, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE Healthcare, Aug 9, 2005 |