BEUDAMED
    FDA Recall Terminated

    Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.

    Recall: Z-0827-2012 · Initiated May 1, 2011

    Recall

    Recall Number
    Z-0827-2012
    Event Number
    60761
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 1, 2011
    Posted
    January 20, 2012
    Terminated
    January 24, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.

    Reason

    The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.

    Action

    The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.

    Distribution

    Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.

    Quantity

    3