Medical device recalls Moderate risk

Invacare Corporation recalls Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) M…

Recall date
November 12, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0446-2022
FDA classification
Class II
Brand / firm
Invacare Corporation
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

Get recall alerts

Free email alert whenever Invacare Corporation has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Invacare Corporation