05

Oct

2008

Cl Il Definium 8000 Digital Radiographic System.

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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