Z-2653-2017 Class II Terminated

Recalled by Shimadzu Medical Systems Usa Com — Torrance, CA

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
May 23, 2017
Termination Date
October 1, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1673 units total

Product Description

SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position

Reason for Recall

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

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

Code Information

Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001