BEUDAMED
    FDA Recall Terminated

    syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063

    Recall: Z-1235-2009 · Initiated January 12, 2009

    Recall

    Recall Number
    Z-1235-2009
    Event Number
    51423
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 12, 2009
    Posted
    April 28, 2009
    Terminated
    September 23, 2009
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063

    Reason

    Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability, inaccurate results during image measurements, incorrect review or diagnosis of displayed or printed images, measurement inaccuracies from the host modality and image

    Action

    syngo Imaging has issued an Addendum to the User Manual, which was distributed to affected customers via Update Instructions IM118/08/S in November, 2008. Two safety related hotfixes (VB20G_HF4 and VB30A_HF26) will be released to those affected only after Update Instructions IM118/08/S has been performed. The addendum informs the user about safety relevant notes which pertain to syngo Imaging versions VB20G and VB30A. Update is a prerequisite for the following safety related hotfixes: VB20G_HF4 and VB30A_HF26.

    Distribution

    Nationwide Distribution.

    Quantity

    55 units