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Recall Observatory FDA recall evidence

Device product

Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

Z-0445-2022

November 12, 2021

Class II

Product summary

Firm
Invacare Corporation
Event
Event 89062
Status
Ongoing
Classification
Class II
Quantity
1477 units US; 1226 units OUS
Official record key
device-enforcement:Z-0445-2022

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: TDXSP2 00841447100911 TDXSP2-CG 00841447100942 TDXSP2-MCG 00841447100966 TDXSP2HD 00841447108641 TDXSP2HD-CG 00841447111207 TDXSP2HD-MCG 00841447111214 TDXSP2V 00841447101512 TDXSP2V-HD 00841447102052 TDXSP2X-CG 00841447101000 TDXSP2X-MCG 00841447101017

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