PlainRecalls
FDA Devices Moderate 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

Reported: January 12, 2022 Initiated: November 12, 2021 #Z-0446-2022

Product 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 for Recall

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

Details

Recalling Firm
Invacare Corporation
Units Affected
303 units US; 20 units OUS
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
Location
Elyria, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by Invacare Corporation. Units affected: 303 units US; 20 units OUS.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0446-2022.