BEUDAMED
    FDA Recall Terminated

    MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging

    Recall: Z-2979-2011 · Initiated June 20, 2011

    Recall

    Recall Number
    Z-2979-2011
    Event Number
    59170
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 20, 2011
    Posted
    August 10, 2011
    Terminated
    January 14, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging

    Reason

    Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. Locally, the cable connections overheated, making servicing necessary.The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

    Action

    Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 20, 2011 to all affected customers. The letter describes the product, problem, and actions that will be taken. The letter informs customers that an inspection of the gradient cable connections and an emergency shutdown mechanism will be installed by a field service representative during a visit to all affected locations.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of AK, FL, GA, IL, MA, MI, MN, MT, NC, NJ, NY, OH, TX, UT, VA, WA, and WV.

    Quantity

    26