Medical device recalls Moderate risk

Shimadzu Medical Systems recalls X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit,…

Recall date
March 31, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1585-2016
FDA classification
Class II
Brand / firm
Shimadzu Medical Systems
Sold / distributed
Nationwide Distribution

Why it was recalled

Report of unintentional movement of table to reverse tilting.

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

What was recalled

X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

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