# FDA recall Z-0446-2022

> **Invacare Corporation** · Class II · device recall initiated 2021-11-12.

## 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

- **Recall number:** Z-0446-2022
- **Recalling firm:** Invacare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-12
- **Report date:** 2022-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elyria, OH, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0446-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0446-2022. Source: US FDA. Licensed CC0.

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