Recall Z-0219-05 ยท KPR System, X-Ray, Stationary
General Electric Med Systems LLC
Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
| 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 | 2716 |
| Distribution | globally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |