BEUDAMED
    FDA Recall Terminated

    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.

    Recall: Z-0047-2018 · Initiated September 18, 2017

    Recall

    Recall Number
    Z-0047-2018
    Event Number
    78086
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    September 18, 2017
    Terminated
    December 11, 2017
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60192-2061

    Description

    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.

    Reason

    The torque wrench used to tighten system bolts during installation was found to be out of tolerance

    Action

    The recall was initiated via phone and visit beginning 9/18/2017.

    Distribution

    Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.

    Quantity

    16 devices