FDA recall Z-1951-2019

GE Healthcare, LLC · Class II · device

Product

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Reason for recall

Additional low dose radiation exposure.

Distribution

Worldwide - US Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2019-01-19
Report date
2019-07-24
Voluntary/Mandated
FDA Mandated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1951-2019