BEUDAMED
    FDA Enforcement Class II Terminated

    ECHELON MRI System

    Recall: Z-2337-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2337-2021
    Event ID
    88452
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Healthcare Americas Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    July 29, 2021
    Classification Date
    August 24, 2021
    Termination Date
    September 8, 2023
    Address
    1959 Summit Commerce Park, N/A, Twinsburg, OH, 44087-2371, United States

    Description

    ECHELON MRI System

    Reason

    There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.

    Code Info

    V001-V070, V952

    Distribution

    Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.

    Quantity

    472 (US); 10 (OUS) total