BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-2653-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2653-2017
    Event ID
    77351
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems Usa Com
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2017
    Initiation Date
    May 23, 2017
    Classification Date
    June 29, 2017
    Termination Date
    October 1, 2019
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    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

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

    Code Info

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

    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

    Quantity

    1673 units total