Shimadzu Medical Systems Usa Com recalls SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and…

Recall date

May 23, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2655-2017

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 FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals