GE Healthcare, LLC: Medical Device Recall in 2021 - (Recall #: Z-1900-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Product Classification:

Class II

Date Initiated: June 14, 2021

Date Posted: July 7, 2021

Recall Number: Z-1900-2021

Event ID: 88116

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3665

Code Information:

Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2

Distribution Pattern:

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

Voluntary or Mandated:

FDA Mandated