BEUDAMED
    FDA Enforcement Class II Terminated

    SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.

    Recall: Z-0096-2021 · Reported October 21, 2020

    Enforcement

    Recall Number
    Z-0096-2021
    Event ID
    86318
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Handicare AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 21, 2020
    Initiation Date
    August 21, 2020
    Classification Date
    October 9, 2020
    Termination Date
    January 30, 2023
    Address
    Maskinvagen 17, N/A, Lulea, N/A, N/A, Sweden

    Description

    SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.

    Reason

    Carry bar may detach during use of mobile lifts and ceiling lifts equipped with the Swifthook component.

    Code Info

    a. Model number: 70200008; b. Model number: 60600003; Serial Numbers 660311979, 660311759, 010733176902042221660312235, 660311299, 660312299 660311338, 7331769020422, 660311817,660311846, 660311847, 660311848, 6603118540422, 660311855, 6603118560422, 660311849, 660311850, 660311851, 660311852, 660311877, 660311878, 660311880, 660311941, 660311942, 660311968, sales order number 100931 (serial number could not be located)

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, IL, MD, MI, MN, NH, NJ, NY, ON, PA, TX, VA, WA, WI and the countries of Australia, Belgium, Canada, Chile, Denmark, Finland, Germany, Iceland, Ireland, Israel, Japan, Lithuania/ Lathvia, Malaysia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Spain, Sweden, Taiwan the Netherlands, UAE, UK.

    Quantity

    6716 units (585 in US; 6131 in OUS)