BEUDAMED
    FDA Recall Terminated

    Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

    Recall: Z-2245-2016 · Initiated June 23, 2016

    Recall

    Recall Number
    Z-2245-2016
    Event Number
    74620
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 23, 2016
    Terminated
    February 20, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

    Reason

    Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

    Action

    Siemens released and mailed to customers a notice with software update VB30B instructions via update instruction SY018/16/P for customers to follow until the update can be made. The letter also described the software issues involved; and asked customers to include the letter in the operator's manual until the update is performed. Customers are to ensure that all necessary personnel are aware of the situation.

    Distribution

    Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.

    Quantity

    50 units