FDA-Device2021-07-07Class II
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
GE Healthcare, LLC
Hazard
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Sold states
3,665 (US = 956; OUS = 2,709)
Affected count
3665
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1900-2021Don't want to check this manually?
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