FDA Device recall Z-0446-2022
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-…
- FDA Device
- Class II
- ongoing
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of 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-… by Invacare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0446-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-12 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Invacare |
| Distribution | US |
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
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
Identifiers
| code_info | LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 008414471…LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0446-2022%22
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