BEUDAMED
    FDA Recall Terminated

    SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

    Recall: Z-1455-2018 · Initiated February 15, 2018

    Recall

    Recall Number
    Z-1455-2018
    Event Number
    79428
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 15, 2018
    Terminated
    April 8, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

    Reason

    to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

    Action

    The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1301 units will consist of the following: 1. You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3. You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). For further questions, please call (610) 219-4834.

    Distribution

    USA (nationally) Distribution.

    Quantity

    1301