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.
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