BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated November 12, 2021

    Recall

    Recall Number
    Z-0446-2022
    Event Number
    89062
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    ITI
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    November 12, 2021
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    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

    Action

    Invacare issued Urgent Medical Device Letter issued on 11/12/21 to consignees who received devices with LiNX Gyro modules containing firmware version 6.1.2. This letter also contains instructions for consignees who upgraded devices in the field to version 6.1.2. A Consumer Letter will be provided on the recall website for Providers to send to end users who are impacted. Letter states reason for recall, health risk and action to take: Visit www. Invacare.com/RC916 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of power wheelchair serial numbers and/or LiNX Gyro Modules sold to you and instructions to conduct this field correction. You will be prompted to provide responses to information requested regarding this field correction and affected units. " The account number required to access your list of impacted devices appears directly at the end of your company name in the mailing address. For example, ABC COMPANY-XXXXX. " The mailing postal code will also be required to log into your account. 2. Stop using LiNX Gyro Module firmware version 6.1.2 on all power wheelchair programming tools and stored electronic media. 3. Immediately update any LiNX Access iOS and LiNX Access PC tools containing LiNX Gyro Module firmware version 6.1.2 to the latest LiNX Access iOS or LiNX Access PC tool version. 4. Locate the power wheelchairs with affected LiNX Gyro Modules per the date ranges above. 5. For power wheelchairs built prior to the date ranges above, review your customer records to identify whether you have installed LiNX firmware version 6.1.2 on any LiNX Gyro-equipped power wheelchairs since the January 14, 2021 release date of firmware version 6.1.2. Note: If you do not have record of the firmware version installed on the LiNX Gyro Modules you have purchased from Invacare, you must connect to the LiNX system on the wheelchair using the LiNX Access tool to determine the firmware version of the Gyro

    Distribution

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

    Quantity

    303 units US; 20 units OUS