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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