Skip to content
Recall Observatory FDA recall evidence

Device product

Revolution Apex, Revolution CT with Apex Edition

Z-0815-2022

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-0815-2022

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 Apex, Revolution CT with Apex Edition

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.