FDAClass IIJuly 24, 2019

Revolution CT scanners Product Usage: The system is recall

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Why was Revolution CT scanners Product Usage: The system is recalled?

Additional low dose radiation exposure.

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

Product
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Recalling firm
GE Healthcare, LLC
Quantity
857 (US = 195: OUS = 662)
Distribution
Worldwide - US Nationwide Distribution
Recall date
July 24, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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