Revolution EVO recall: Software Issue
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Why was Revolution EVO recalled?
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
- Product
- Revolution EVO, Optima CT660, Optima CT680 CT Systems.
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 3665
- Distribution
- 3,665 (US = 956; OUS = 2,709)
- Recall date
- July 7, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)