Feb

2015

GE Revolution CT Cl II

Company:GE Healthcare
Date of Enforcement Report 2/4/2015
Class lI:

PRODUCT

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
Recall Number Z-0955-2015

REASON
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI 11/12/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13

DISTRIBUTION
CA, FL, IL, NY, UT and WA.

___________________________________

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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GE Revolution CT Cl II

Amy Sellers

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