BEUDAMED
    FDA Recall Terminated

    Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +

    Recall: Z-0322-03 · Initiated July 10, 2002

    Recall

    Recall Number
    Z-0322-03
    Event Number
    25075
    Firm
    Siemens Medical Systems Inc
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 10, 2002
    Posted
    December 5, 2002
    Terminated
    March 24, 2003
    Address
    186 Wood Ave, So Iselin, NJ, 08830

    Description

    Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +

    Reason

    Head holder cannot be properly secured on the table top.

    Action

    Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.

    Distribution

    The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.

    Quantity

    250