FDA-Device2017-07-05Class II
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
Shimadzu Medical Systems Usa Com
Hazard
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Sold states
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
Affected count
1673 units total
Manufactured in
20101 S Vermont Ave, N/A, Torrance, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2655-2017Don't want to check this manually?
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