BEUDAMED
    FDA Recall Terminated

    Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems

    Recall: Z-0016-2014 · Initiated May 6, 2013

    Recall

    Recall Number
    Z-0016-2014
    Event Number
    65161
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 6, 2013
    Posted
    November 1, 2013
    Terminated
    November 6, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems

    Reason

    Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho

    Action

    Siemens initiated this correction on May 6, 2013 by sending Update InstructionXP005/13/S. Firm subsequently issued a letter on June 3, 2013 to all accounts. 1. Siemens Field Modification of the Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, which improves the signal transmission for the automatic exposure control, is available as of May 2013, and systems will be updated within one year. 2. The revised software fix for models Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, will be provided to all identified customers at no charge. 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. Siemens Medical Solutions USA, Inc., will notify the FDA district office in Philadelphia, Pennsylvania, with reports of progress regarding this field correction.

    Distribution

    Nationwide Distribution

    Quantity

    23