BEUDAMED
    FDA Recall Terminated

    Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.

    Recall: Z-0102-2009 · Initiated August 22, 2008

    Recall

    Recall Number
    Z-0102-2009
    Event Number
    49496
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 22, 2008
    Posted
    October 15, 2008
    Terminated
    November 19, 2008
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.

    Reason

    Image may not be visible after merge.

    Action

    The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.

    Distribution

    Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI.

    Quantity

    59 units