medical Class II Updated 2021-07-07

GE Healthcare, LLC recalls Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Recalled Product

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Hazard / Issue

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

Issued by

FDA

Distribution: 3,665 (US = 956; OUS = 2,709)
Lot/Code Info: Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
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