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 form, as well as an X-ray generator/power unit.
Recall
- Recall Number
- Z-1134-2008
- 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 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 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)