Recall Z-1611-2008 ยท IXR Table, Radiographic, Tilting
GE Healthcare
Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. T
| Date | Sep 19, 2008 (initiated Jan 2, 2008) |
| Status | Terminated |
| Reason | GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I |
| Root cause | Nonconforming Material/Component |
| Action | A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed. |
| Quantity | 2863 total (2744 US / 119 OUS) |
| Distribution | Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973039 | LEGACY/LEGACY-D TABLE GE Medical Systems, Oct 16, 1997 |