BEUDAMED
    FDA Enforcement Class II Terminated

    Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

    Recall: Z-2349-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2349-2021
    Event ID
    88365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oakworks Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    June 29, 2021
    Classification Date
    August 25, 2021
    Termination Date
    October 5, 2023
    Address
    923 E Wellspring Rd, N/A, New Freedom, PA, 17349-8408, United States

    Description

    Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219

    Reason

    Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional

    Code Info

    Serial Number/Part Number VCF766794 USGNV22723723MTTZZCE2S; VCF767303 USGNV23023723MTTZZ2S; VCF771999 USGNV23023723MTTZZ2S; VCF774252 USGNV23023723MTTZZ2S; VCF776073 USGNV23023723MTTZZ2S; VCF776198 USGNV23023723MTTZZ2S; VCF778246 USGNV23023723MTTZZ2S; VCF778247 USGNV23023723MTTZZ2S; VCF779362 USGNV23023723MTTZZ2S; VCF780260 USGNV23023723MTTZZ2S; VCS781126 USGNV13023723MTTZZ2S; VCF783652 USGNV22723723MTTZZF82S; VCF783969 USGNV23023723MTTZZF82S; VCF785961 USGNV22723723MTTZZCE2S; VCS766698 USGNV12723723MTTZZF62S; VCF768278 USGNV23023723MTTZZCEDRMC2S; VCF770016 USGNV23023723MTTZZ2S; VCF770017 USGNV23023723MTTZZ2S; VCF770571 USGNV23023723MTTZZCE2S; VCF771782 USGNV23023723MTTZZF8MC2S; VCF776974 USGNV22723723MTTZZ2S; VCF778602 USGNV23023723MTTZZ2S; VCF779609 USGNV23023723MTTZZF8CE2S; VCF781198 USGNV23023723MTTZZ2S; VCF784255 USGNV23023723MTTZZCE2S; VCF785376 USGNV23023723MTTZZ2S; VCF785650 USGNV23023723MTTZZF8MC2S; VCF786137 USGNV23023723MTTZZ2S; VCF786173 USGNV23023723MTTZZCE2S; VCF771553 USGNV23023723MTTZZCEMC2S; VCF771554 USGNV23023723MTTZZCEMC2S; VCF785065 USGNV22723723MTTZZF8CEDRDL2S; VCF771992 USGNV23023723MTTZZF8DRDL2S; VCF771993 USGNV23023723MTTZZF8DRDL2S; VCF782916 USGNV23023723MTTZZF8DRDL2S; VCF772035 USGNV22723723MTTZZ2S; VCF777288 USGNV22723723MTTZZ2S; VCF779024 USGNV22723723MTTZZ2S; VCF779025 USGNV22723723MTTZZ2S; VCF779026 USGNV22723723MTTZZ2S; VCF780977 USGNV22723723MTTZZ2S; VCF785219 USGNV22723723MTTZZ2S; VCF771311 USGNV23023723MTTZZ2S; VCF785744 USGNV22723723MTTZZCE2S; VCS772698 USGNV12723723MTTZZ2S; VCF771236 USGNV22723723MTTZZF8CE2S; VCF775658 USGNV23023723MTTZZ2S; VCF776370 USGNV23023723MTTZZ2S; VCF792903 USGNV23023723MTTZZMC2S; VCF773748 USGNV23023723MTTZZF8MC2S; VCF773748 USGNV23023723MTTZZCE2S; VCF779429 USGNV23023723MTTZZF8CE2S; VCF779921 USGNV23023723MTTZZF82S; VCF783233 USGNV23023723MTTZZ2S; VCF786329 USGNV22723723MTTZZ2S;

    Distribution

    Nationwide

    Quantity

    55 units