BEUDAMED
    FDA Enforcement Class II Terminated

    Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    Recall: Z-2128-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2128-2019
    Event ID
    83144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Burlington Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2019
    Initiation Date
    June 7, 2019
    Classification Date
    July 30, 2019
    Termination Date
    April 28, 2023
    Address
    PO Box 3194, 3 Elmhurst St, Newport News, VA, 23603-1137, United States

    Description

    Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    Reason

    The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

    Code Info

    Serial Numbers: 419558 419557 414132

    Distribution

    US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

    Quantity

    3