BEUDAMED
    FDA Recall Terminated

    syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.

    Recall: Z-1704-2015 · Initiated May 6, 2015

    Recall

    Recall Number
    Z-1704-2015
    Event Number
    71206
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 6, 2015
    Posted
    June 2, 2015
    Terminated
    August 17, 2016
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints.

    Reason

    A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.

    Action

    Siemens sent an Safety Advisory Notice, dated May 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were given work around instructions to follow and informed that a software fix would be implemented to permanently resolve the issue. For further questions please call (610) 219-6300.

    Distribution

    Nationwide Distribution

    Quantity

    131