Medical device recalls Moderate risk

Shimadzu Medical Systems recalls Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to…

Recall date
November 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0451-2016
FDA classification
Class II
Brand / firm
Shimadzu Medical Systems
Sold / distributed
US Distribution and Internationally to Canada

Why it was recalled

The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.

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

What was recalled

Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.

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