BEUDAMED
    FDA Enforcement Class II Terminated

    Sensis Vibe System, Model Number 11007642, with software version VD10B.

    Recall: Z-0936-2019 · Reported March 6, 2019

    Enforcement

    Recall Number
    Z-0936-2019
    Event ID
    81959
    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 6, 2019
    Initiation Date
    November 29, 2018
    Classification Date
    February 23, 2019
    Termination Date
    May 7, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    Sensis Vibe System, Model Number 11007642, with software version VD10B.

    Reason

    A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.

    Code Info

    Serial Number 120019

    Distribution

    The products were distributed to the following US states: NJ.

    Quantity

    1