FDA recall Z-0446-2022

Invacare Corporation · Class II · device

Product

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2021-11-12
Report date: 2022-01-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elyria, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2022