BEUDAMED
    FDA Enforcement Class II Ongoing

    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

    Recall: Z-0445-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0445-2022
    Event ID
    89062
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 12, 2021
    Classification Date
    January 3, 2022
    Address
    1200 Taylor St, N/A, Elyria, OH, 44035-6248, United States

    Description

    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

    Reason

    Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury

    Code Info

    LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: TDXSP2 00841447100911 TDXSP2-CG 00841447100942 TDXSP2-MCG 00841447100966 TDXSP2HD 00841447108641 TDXSP2HD-CG 00841447111207 TDXSP2HD-MCG 00841447111214 TDXSP2V 00841447101512 TDXSP2V-HD 00841447102052 TDXSP2X-CG 00841447101000 TDXSP2X-MCG 00841447101017

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.

    Quantity

    1477 units US; 1226 units OUS