BEUDAMED
    FDA Recall Terminated

    SOMATOM Emotion 6 (Model 10165888)

    Recall: Z-2472-2018 · Initiated February 1, 2018

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    Recall

    Recall Number
    Z-2472-2018
    Event Number
    79665
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 1, 2018
    Posted
    March 30, 2018
    Terminated
    May 1, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Emotion 6 (Model 10165888)

    Reason

    A potential risk of unnecessary radiation exposure due to a software issue

    Action

    Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.

    Distribution

    Nationwide