FDA-Device2022-04-13Class II
Revolution CT, Revolution CT ES
GE Healthcare, LLC
Hazard
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Sold states
Worldwide - US Nationwide distribution.
Affected count
273 (51 US; 222 OUS) in total
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Revolution CT, Revolution CT ES
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0816-2022Don't want to check this manually?
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