Medical device recalls Moderate risk

Fujifilm Medical Systems U.S.A., Inc. recalls Fujifilm FDR Go Plus mobile X-ray system

Recall date
July 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2441-2019
FDA classification
Class II
Brand / firm
Fujifilm Medical Systems U.S.A., Inc.
Sold / distributed
Nationwide

Why it was recalled

The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD)

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

What was recalled

Fujifilm FDR Go Plus mobile X-ray system

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