Product Safety Recalls

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GE Healthcare, LLC Recall 88116

Description: Revolution EVO, Optima CT660, Optima CT680 CT Systems.

GE Healthcare, LLC Recall 88116 Information

Mandated?FDA Mandated
Recall NumberZ-1900-2021
Event ID88116
Event DescriptionRevolution EVO, Optima CT660, Optima CT680 CT Systems.
Product TypeDevices
Distribution3,665 (US = 956; OUS = 2,709)
Recall ReasonImproperly loaded software options may result in additional X -ray radiation exposure to the patient.
Device Classification20210707
Device Code InfoOptima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
Center Classification Date20210625
Recall Initiation Date20210614
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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