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GE Healthcare recalls The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop
Recalled February 4, 2015 · FDA recall Z-0955-2015 · GE Healthcare
Hazard
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner. · FDA Class II
Units
13 units
Sold at
US Distribution to the states of CA, FL, IL, NY, UT and WA.
Description
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
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.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →