BEUDAMED
    FDA Recall Terminated

    MAGNETOM Avanto, Espree, Trio A Tim System. Nuclear magnetic resonance imaging.

    Recall: Z-2021-2011 · Initiated March 3, 2011

    Recall

    Recall Number
    Z-2021-2011
    Event Number
    58080
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2011
    Posted
    April 18, 2011
    Terminated
    December 9, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    MAGNETOM Avanto, Espree, Trio A Tim 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. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.

    Action

    Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils. Further questions regarding this recall please call (610) 448-3237.

    Distribution

    Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY(every State except VT).

    Quantity

    1419