Recall Z-1477-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic 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 | 437 |
| 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
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM GE Medical Systems, Jun 8, 2001 |