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GE Healthcare, LLC recalls Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Recalled July 7, 2021 · FDA recall Z-1900-2021 · GE Healthcare
Hazard
Improperly loaded software options may result in additional X -ray radiation exposure to the patient. · FDA Class II
Units
3665
Sold at
3,665 (US = 956; OUS = 2,709)
Description
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Product
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →