Company: GE Healthcare
Date of Enforcement Report 10/1/2008
Class:ll
PRODUCT
GE Healthcare Definium 8000 Digital Radiographic System, Recall # Z-1882-2008
REASON
Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs readings reported from the system could be up to ten times higher than what was actually exposed to the patient. Occurrence is limited to the first exposure after the focal spot is switched from small to large. The generator incorrectly applies the small filament limit to the large focal spot, which can cause the large focal spot to produce less current. Subsequent large focal spot exposures will not exhibit this issue.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
454 units
DISTRIBUTION
Nationwide and Internationally
