BEUDAMED
    FDA Recall Terminated

    DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"

    Recall: Z-0941-2012 · Initiated December 29, 2011

    Recall

    Recall Number
    Z-0941-2012
    Event Number
    61010
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 29, 2011
    Posted
    February 2, 2012
    Terminated
    March 24, 2014
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"

    Reason

    It has been found that some of the starter cables used for x-ray tube high speed rotation are not sufficiently durable.

    Action

    The recall notification titled "URGENT: MEDICAL DEVICE CORRECTION", was sent on 12/29/11 to customers via certified mail. The letter informed the customer of an issue with the starter cable used for high speed rotation on the Radrex X-Ray System. The letter also informs customers of the corrective measures: a replacement cable will be installed on your system to prevent this issue from occurring. An 800 number was provided for any questions regarding the letter.

    Distribution

    Class II Recall - Nationwide Distribution (USA) - Including the states of VA, IL, CA, PA, TN, OH, LA, TX, OK, AR, AZ, MS, WV, TN, WI, NJ, MN, NY, IA, FL, and Washington D.C.

    Quantity

    39