FDA recall Z-0242-2022

GE Healthcare, LLC · Class II · device

Product

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Reason for recall

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

Distribution

Worldwide and US Nationwide Distribution

Key facts

Status: Ongoing
Initiation date: 2021-06-30
Report date: 2021-12-01
Voluntary/Mandated: FDA Mandated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0242-2022