Revolution EVO, Optima CT660, Optima CT680 CT Systems.
- Company
- Ge Healthcare, Llc
- Recall Initiated
- June 14, 2021
- Recall Number
- Z-1900-2021
- Quantity
- 3665
- Firm Location
- Waukesha, WI
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)
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
Root Cause
Radiation Control for Health and Safety Act
Action Taken
GE Healthcare will send an Important Electronic Product Radiation Warning letter to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take to prevent this issue.
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