BEUDAMED
    FDA Recall Terminated

    Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.

    Recall: Z-1892-2010 · Initiated April 6, 2010

    Recall

    Recall Number
    Z-1892-2010
    Event Number
    55651
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 6, 2010
    Posted
    June 24, 2010
    Terminated
    July 5, 2012
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.

    Reason

    Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.

    Action

    The recalling firm sent a Customer Safety Advisory Notice, dated 04-06-2010, to customers explaining when the malfunction occurs and the potential risks, steps to avoid potential risk of the issue by ensuring that the RIS works according to DICOM Standard and does not create double study instance UIDs. Siemens Service Reps will contact the consignees in a timely manner to check if there are symptoms for the reported issues. The issue will be resolved with a Software-Update for each affected version, except for version VB20. All customers on VB20 will be upgraded.

    Distribution

    Nationwide Distribution -- Including CT, NM, & WI.

    Quantity

    3 units