BEUDAMED
    FDA Enforcement Class II Terminated

    Syngo.via systems with SW VB20A

    Recall: Z-0808-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0808-2018
    Event ID
    79178
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    August 31, 2017
    Classification Date
    March 1, 2018
    Termination Date
    October 1, 2018
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Syngo.via systems with SW VB20A

    Reason

    A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.

    Code Info

    10496180

    Distribution

    Nationwide Distribution.

    Quantity

    30