Oct

2008

Cl Il GE Definium 8000 Digital Radiographic sys.

Company: GE Healthcare
Date of Enforcement Report 10/1/2008
Class:ll

PRODUCT
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis, Recall # Z-1822-2008

REASON
Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover). This lost anatomy cannot be recovered or visualized by retrospective reconstruction processing.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated March 7, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
127 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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Cl Il GE Definium 8000 Digital Radiographic sys.

Amy Sellers

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