BEUDAMED
    FDA Enforcement Class II Ongoing

    Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C

    Recall: Z-0446-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0446-2022
    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 AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C

    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: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658

    Distribution

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

    Quantity

    303 units US; 20 units OUS