GE Healthcare, LLC: Medical Device Recall in 2022 - (Recall #: Z-0815-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Revolution Apex, Revolution CT with Apex Edition

Product Classification:

Class II

Date Initiated: June 30, 2021

Date Posted: April 13, 2022

Recall Number: Z-0815-2022

Event ID: 89762

Reason for Recall:

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

Status: Ongoing

Product Quantity: 273 (51 US, 222 OUS) in total

Code Information:

Revolution Apex, Revolution CT with Apex Edition

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

FDA Mandated