Medical device recalls Moderate risk

GE Healthcare, LLC recalls Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed…

Recall date
January 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1951-2019
FDA classification
Class II
Brand / firm
GE Healthcare, LLC
Sold / distributed
Worldwide - US Nationwide Distribution

Why it was recalled

Additional low dose radiation exposure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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