FDA recall Z-2004-2021

Product

Revolution CT

Reason for recall

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

Distribution

Worldwide distribution - US Nationwide

Key facts

Status

Completed

Initiation date

2021-03-19

Report date

2021-07-14

Voluntary/Mandated

FDA Mandated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2004-2021