Device product

Revolution CT, Revolution CT ES

Z-0816-2022

June 30, 2021

Class II

Product summary

Firm: GE Healthcare, LLC
Event: Event 89762
Status: Ongoing
Classification: Class II
Quantity: 273 (51 US; 222 OUS) in total
Official record key: device-enforcement:Z-0816-2022

Official wording

Reason: The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

Code information: Revolution CT, Revolution CT ES

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.