BEUDAMED
    FDA Recall Terminated

    Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions.

    Recall: Z-0849-04 · Initiated March 19, 2004

    Recall

    Recall Number
    Z-0849-04
    Event Number
    28693
    Firm
    USA Instruments Inc.
    FEI Number
    3005214683
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 19, 2004
    Posted
    July 20, 2004
    Terminated
    March 1, 2012
    Address
    1515 Danner Dr, Aurora, OH, 44202-9273

    Description

    Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions.

    Reason

    A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.

    Action

    The firm notified the regional Siemens Service Centers by letter on 3/19/2004. The affected coils will be returned to the recalling firm for modification.

    Distribution

    The device was shipped to domestic consignees located CT, NY, PA, NC, GA, FL, OH, IN, MN, IL, UT, CA, OR; and foreign consignees in Austria, Denmark, Spain, Hong Kong, China, Netherlands, Japan, Taiwan, Korea, Australia, Turkey, Brazil, Germany.

    Quantity

    79