BEUDAMED
    FDA Recall Terminated

    EVO Excel, Emission Computed Tomographic System, Material Number 10910501

    Recall: Z-0372-2019 · Initiated October 5, 2018

    Recall

    Recall Number
    Z-0372-2019
    Event Number
    80927
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    1000514697
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 5, 2018
    Terminated
    February 11, 2021
    Address
    2501 Barrington Rd, Hoffman Estates, IL, 60192-2061

    Description

    EVO Excel, Emission Computed Tomographic System, Material Number 10910501

    Reason

    The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,

    Action

    Siemens disseminated the notices by letter on 10/05/2018. Firm will deliver a Symbia Evo Excel Addendum and DVD addendum with this updated information at a later date.

    Distribution

    Worldwide

    Quantity

    264 units