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FDASeptember 21, 2020device

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

What to do

FDA enforcement status: Terminated

Brands named

ge healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. — Recall Details · AllClear