BEUDAMED
    FDA Recall Terminated

    Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.

    Recall: Z-0940-2012 · Initiated January 26, 2012

    Recall

    Recall Number
    Z-0940-2012
    Event Number
    61030
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 26, 2012
    Posted
    February 2, 2012
    Terminated
    January 31, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic resonance imaging system.

    Reason

    During product monitoring firm has discovered 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 existed for a cable connection to become overheated, leading to the emission of smoke and possible material damage. Firm preventively checked the gradient cabl

    Action

    Siemens Medical Solutions sent a "CUSTOMER SAFETY ADVISORY NOTICE" letter dated November 24, 2010 to all affected customers. The letter described the product, problem, and actions to be taken. Contact the firm at 610-219-4834 for questions regarding this recall.

    Distribution

    Nationwide Distribution-including the states of AK, AZ, CA, CT, DE, FL, GA, IL, IN, KS, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.

    Quantity

    128