Medical device recalls Moderate risk

Fujifilm Medical Systems U.S.A., Inc. recalls Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Recall date
April 1, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1599-2016
FDA classification
Class II
Brand / firm
Fujifilm Medical Systems U.S.A., Inc.
Sold / distributed
Nationwide Distribution.

Why it was recalled

Reports of failure of the device's power supply.

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

What was recalled

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

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