Recalls / —

—#187915

Product

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K131576

Affected 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

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

3,665 (US = 956; OUS = 2,709)

Timeline

Recall initiated

2021-06-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #187915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.