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GE Healthcare, LLC recalls Revolution Apex, Revolution CT with Apex Edition
Recalled April 13, 2022 · FDA recall Z-0815-2022 · GE Healthcare
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. · FDA Class II
Units
273 (51 US, 222 OUS) in total
Sold at
Worldwide - US Nationwide distribution.
Description
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Product
Revolution Apex, Revolution CT with Apex Edition
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →