Device 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
Z-2655-2017
Product summary
- Event
- Event 77351
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1673 units total
- Official record key
device-enforcement:Z-2655-2017
Official wording
Reason: Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
Code information: Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
Distribution pattern: 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
Derived failure modes
-
Unknown
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.