FDA-Device2022-04-13Class II
Revolution Apex, Revolution CT with Apex Edition
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 Apex, Revolution CT with Apex Edition
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0815-2022Don't want to check this manually?
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