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 form, as well as an X-ray generator/power unit.
Recall
- Recall Number
- Z-1133-2008
- Event Number
- 48144
- Firm
- GE Healthcare
- FEI Number
- 2126677
- Product Code
- KPR
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- December 17, 2007
- Posted
- September 4, 2008
- Terminated
- September 10, 2008
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
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 form, as well as an X-ray generator/power unit.
GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue.
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.
MD, FL, AZ, TX, MS, NY, OH, CA, GERMANY, and FRANCE.
14 devices (12US & 2 OUS)