Medical device recalls Moderate risk

Shimadzu Medical Systems Usa Com recalls SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

Recall date
May 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2654-2017
FDA classification
Class II
Brand / firm
Shimadzu Medical Systems Usa Com
Sold / distributed
Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan

Why it was recalled

Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.

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

What was recalled

SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

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