FDAClass IIJuly 14, 2021

The system is intended to produce cross-sectional recall

The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…

Why was The system is intended to produce cross-sectional recalled?

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

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
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
Recalling firm
GE Healthcare, LLC
Distribution
US
Recall date
July 14, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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