BEUDAMED
    FDA Recall Terminated

    Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

    Recall: Z-1643-2008 · Initiated March 10, 2008

    Recall

    Recall Number
    Z-1643-2008
    Event Number
    47524
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 10, 2008
    Posted
    August 24, 2008
    Terminated
    November 19, 2008
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

    Reason

    The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study.

    Action

    The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions IM011/08/S. The letter informs customers of the potential issue and provides instructions to detect its occurrence. A software update to correct the issue is already available. A service representative will visit affected sites to install the software update. If you have questions concerning the advisory letter or you did not receive a letter contact Alexander Vogel at +49 (9131) 84-3840 or alexander.vogel@siemens,com and make reference to complaint 08-1KM-0073 date 2008-03-06.

    Distribution

    The product was shipped to medical facilities in AL, AZ, CA, CO, CT, FL, GA, IA, KS, KY, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, WI, and WV.

    Quantity

    236 units