BEUDAMED
    FDA Enforcement Class II Completed

    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.

    Recall: Z-2591-2020 · Reported July 22, 2020

    Enforcement

    Recall Number
    Z-2591-2020
    Event ID
    85416
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2020
    Initiation Date
    November 4, 2019
    Classification Date
    July 14, 2020
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    Description

    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.

    Reason

    The DAP meters were found to be outside of tolerance.

    Code Info

    Serial numbers LR051A58B027, LR051A58B028, and LR051A58B029.

    Distribution

    US Nationwide distribution including in the states of FL, KY, and LA. There was no government/military/foreign distribution.

    Quantity

    3 devices