Recall Z-0220-05 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
General Electric Med Systems LLC
Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.
| Date | Feb 14, 2006 (initiated Dec 30, 2004) |
| Status | Terminated |
| Reason | Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur. |
| Root cause | Other |
| Action | An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification. |
| Quantity | 921 |
| Distribution | globally |
| 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 |