CLASS II ONGOING Device recall · Reported 12 Jan 2022 · FDA Enforcement Report

TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled

Invacare is recalling TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module, distributed nationwide in the US. The recall was initiated on 12 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLiNX 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

Quantity recalled1477 units US; 1226 units OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0445-2022
FDA event ID: 89062
Recalling firm: Invacare, Elyria, OH
Classification: Class II
Status: Ongoing
Recall initiated: 12 Nov 2021
FDA classified: 3 Jan 2022
Reported: 12 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Wheelchairs, Beds & Lifts

Timeline

12 Nov 2021	Recall initiated by company
3 Jan 2022	Classified by FDA	+52 days
12 Jan 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 89062

This product is part of a recall event; the main page for the event is Aviva FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled.

Reported	Class	Recall	Company	Reason	Where
12 Jan 2022	CLASS II	Aviva FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled	Invacare	Other	Nationwide
12 Jan 2022	CLASS II	Aviva Storm RX with LiNX Gyro Power Wheelchair recalled by Invacare	Invacare	Other	Nationwide

More recalls from Invacare

All 35

Reported	Class	Recall	Company	Reason	Where
30 Aug 2023Device	CLASS II	Dolomite Gloss Rollator - intended to support during recalled	Invacare	Foreign Material	Nationwide
20 Jul 2022Device	CLASS III	Platinum 5NXG Oxygen Concentrator recalled by Invacare	Invacare	Other	18 states
1 Jun 2022Device	CLASS II	TDX SP2 recalled by Invacare	Invacare	Device Malfunction	Nationwide
12 Jan 2022Device	CLASS II	Aviva Storm RX with LiNX Gyro Power Wheelchair recalled by Invacare	Invacare	Other	Nationwide
12 Jan 2022Device	CLASS II	Aviva FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled	Invacare	Other	Nationwide

Other Wheelchairs, Beds & Lifts recalls

All 175

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