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Recall Observatory FDA recall evidence

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

November 12, 2021

Class II

Product summary

Firm
Invacare Corporation
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

    reason.device_software_design · v1.0.0

    firmware version 6.1.2 can