BEUDAMED
    FDA Recall Terminated

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

    Recall: Z-2088-2016 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-2088-2016
    Event Number
    74390
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 9, 2016
    Posted
    June 29, 2016
    Terminated
    March 20, 2017
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

    Reason

    Software error in previous software versions in which two references for the same image may exist in the database.

    Action

    Siemens sent an Customer Information letter dated May 10, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter with software instruction to customers informing them about an upcoming software VB10B under(SY003/16/P) update change and issue that the new software version will address. For further questions, please call (610) 448-6478.

    Distribution

    US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI

    Quantity

    74 systems