FDA recall Z-0816-2022

GE Healthcare, LLC · Class II · device

Product

Revolution CT, Revolution CT ES

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2021-06-30
Report date: 2022-04-13
Voluntary/Mandated: FDA Mandated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0816-2022