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
Z-0446-2022
Product summary
- Event
- Event 89062
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 303 units US; 20 units OUS
- Official record key
device-enforcement:Z-0446-2022
Official wording
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
Code information: LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
Derived failure modes
-
Device software or design
firmware version 6.1.2 can