FDAClass IIJuly 14, 2021

Revolution CT recall

Revolution CT

Why was Revolution CT recalled?

GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

5590000 5590000-6 5590000-2

Product
Revolution CT
Recalling firm
GE Healthcare, LLC
Quantity
197 (US = 40; OUS = 157)
Distribution
Worldwide distribution - US Nationwide
Recall date
July 14, 2021
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls