BEUDAMED
    FDA Enforcement Class II Ongoing

    Permobil TiLite, Models: Aero Z, and ZRA

    Recall: Z-0264-2022 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0264-2022
    Event ID
    88718
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TiSport, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 24, 2021
    Initiation Date
    September 24, 2021
    Classification Date
    November 18, 2021
    Address
    2701 W Court St, N/A, Pasco, WA, 99301-3911, United States

    Description

    Permobil TiLite, Models: Aero Z, and ZRA

    Reason

    Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.

    Code Info

    Manufactured between January 19, 2017 and June 14, 2021 with the serial number range from M2005054 to 1231112011

    Distribution

    US Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL, CA, OH, KY, LA, OK, WI, TX, NC, SD, MN, MA, OR; OUS (Foreign): AUSTRALIA, CANADA, FRANCE, GERMANY, IRELAND, ITALY, UNITED KINGDOM, URUGUAY, NEW ZEALAND, IRELAND, SWEDEN

    Quantity

    5373