FDA-Device2015-02-04Class II
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.
GE Healthcare
Hazard
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
Sold states
US Distribution to the states of CA, FL, IL, NY, UT and WA.
Affected count
13 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief