FDAClass IIApril 13, 2022

Revolution CT recall

Revolution CT, Revolution CT ES

Why was Revolution CT recalled?

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

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?

Revolution CT, Revolution CT ES

Product
Revolution CT, Revolution CT ES
Recalling firm
GE Healthcare, LLC
Quantity
273 (51 US; 222 OUS) in total
Distribution
Worldwide - US Nationwide distribution.
Recall date
April 13, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls