BEUDAMED
    FDA Recall Terminated

    SOMATOM Emotion 16. Computed tomography X-ray system

    Recall: Z-2453-2008 · Initiated August 5, 2008

    Recall

    Recall Number
    Z-2453-2008
    Event Number
    49139
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 5, 2008
    Posted
    September 21, 2008
    Terminated
    November 7, 2008
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    SOMATOM Emotion 16. Computed tomography X-ray system

    Reason

    Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.

    Action

    The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S.

    Distribution

    Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, WA, and WI.

    Quantity

    53 units