BEUDAMED
    FDA Recall Terminated

    Syngo.via. Medical Device Software. Picture archiving and communications system.

    Recall: Z-1303-2018 · Initiated January 8, 2018

    Recall

    Recall Number
    Z-1303-2018
    Event Number
    79532
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 8, 2018
    Posted
    March 20, 2018
    Terminated
    April 22, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Syngo.via. Medical Device Software. Picture archiving and communications system.

    Reason

    A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

    Action

    Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.

    Distribution

    Device is software only. No products are distributed to wholesale dealers, distributers or retailers

    Quantity

    236 units