BEUDAMED
    FDA Recall Terminated

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    Recall: Z-0719-2018 · Initiated April 25, 2017

    Recall

    Recall Number
    Z-0719-2018
    Event Number
    78973
    Firm
    Medistim Asa Okernveien
    FEI Number
    3010790133
    Product Code
    DPW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 25, 2017
    Terminated
    May 3, 2024
    Address
    94 Oslo Norway

    Description

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    Reason

    A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

    Action

    A letter was sent describing the device, reason for the recall, and risk involved. The firm stated that it would ship a VeriQ replacement system without the affected connector being used.

    Distribution

    Distributed to New York.

    Quantity

    2