FDA recall Z-2655-2017

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-05-23

Report date

2017-07-05

Termination date

2019-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2655-2017