Z-1900-2021 Class II Ongoing
FDA device recall Z-1900-2021 was initiated by GE Healthcare, LLC on June 14, 2021 and is designated Class II. Reason for recall: Improperly loaded software options may result in additional X -ray radiation exposure to the patient. The recall status is ongoing. Affected quantity: 3665.
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- June 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 3665
Product Description
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Reason for Recall
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Distribution Pattern
3,665 (US = 956; OUS = 2,709)
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