GE Healthcare, LLC Revolution EVO, Optima CT660, Optima CT680 CT Systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
GE Healthcare, LLC is recalling Revolution EVO, Optima CT660, Optima CT680 CT Systems. due to Improperly loaded software options may result in additional X -ray radiation exposure to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026