30

Dec

2009

Cl Il Revolution XR/d system control room PC

0

Company:GE Medical Systems, LLC.
Date of Enforcement Report 12/30/2009
Class:ll

PRODUCT
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. Recall # Z-0002-2009

REASON
GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into this issue revealed an error in the Revolution XR/d image processing software that controls rotation of collimator coordinates. This error causes the system to display a blank image when Digits to front or Digits to back are selected for off-center collimation exams.

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

VOLUME OF PRODUCT IN COMMERCE
129 units

DISTRIBUTION
Nationwide.

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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