Device product

SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

Z-2654-2017

May 23, 2017

Class II

Product summary

Firm: Shimadzu Medical Systems Usa Com
Event: Event 77351
Status: Terminated
Classification: Class II
Quantity: 1673 units total
Official record key: device-enforcement:Z-2654-2017

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
reason.no_named_rule · v1.0.0

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