FDA recall Z-1900-2021

Product

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Reason for recall

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

Distribution

3,665 (US = 956; OUS = 2,709)

Key facts

Status

Ongoing

Initiation date

2021-06-14

Report date

2021-07-07

Voluntary/Mandated

FDA Mandated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1900-2021