Home / Recalls / Medical Devices
Shimadzu Medical Systems Usa Com recalls SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic an
Recalled July 5, 2017 · FDA recall Z-2655-2017 · Shimadzu Medical Systems Usa Com
Hazard
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange. · FDA Class II
Units
1673 units total
Sold at
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
Description
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Product
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
Manufacturer(s)
Shimadzu Medical Systems Usa Com
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →