Recall Z-1133-2008 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. 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 for
| 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 |