Recall Z-1134-2008 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. The Definium 5000 System is designed to handle radiographic applications using the digital system. The system configuration includes a choice of elevating or non-elevating or no table, a floor column stand with rotating U-arm, and GE's patented Digital detector that captures radiographic images in digital fo
| Date | Sep 4, 2008 (initiated Dec 17, 2007) |
| Status | Terminated |
| Reason | GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A consignee letter dated 12/12/07 was sent to consignees (Director or Manager of Radiological Imaging, Clinical Administrator). The letter stated that an installed collimator failed compliance testing because of a blaze sizing issue. A GE Field Engineer site visit was also conducted (FMI No. 10814 12/18/07) to implement the correction. Contact GE Healthcare at 1-262-544-3894. |
| Quantity | 14 devices (12US & 2 OUS) |
| Distribution | MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063283 | DEFINIUM 5000 X-RAY SYSTEM Sedecal., Sa., Nov 17, 2006 |