Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX… recallZ-0445-2022 · Invacare Corporation · initiated Nov 12, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Invacare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Software design
What the company is doing
Invacare issued Urgent Medical Device Letter issued on 11/12/21 to consignees who received devices with LiNX Gyro modules containing firmware version 6.1.2. This letter also contains instructions for consignees who upgraded devices in the field to version 6.1.2. A Consumer Letter will be provided on the recall website for Providers to send to end users who are impacted. Letter states reason for recall, health risk and action to take: Visit www. Invacare.com/RC916 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of power wheelchair serial numbers and/or LiNX Gyro Modules sold to you and instructions to conduct this field correction. You will be prompted to provide responses to information requested regarding this field correction and affected units. " The account number required to access your list of impacted devices appears directly at the end of your company name in the mailing address. For example, ABC COMPANY-XXXXX. " The mailing postal code will also be required to log into your account. 2. Stop using LiNX Gyro Module firmware version 6.1.2 on all power wheelchair programming tools and stored electronic media. 3. Immediately update any LiNX Access iOS and LiNX Access PC tools containing LiNX Gyro Module firmware version 6.1.2 to the latest LiNX Access iOS or LiNX Access PC tool version. 4. Locate the power wheelchairs with affected LiNX Gyro Modules per the date ranges above. 5. For power wheelchairs built prior to the date ranges above, review your customer records to identify whether you have installed LiNX firmware version 6.1.2 on any LiNX Gyro-equipped power wheelchairs since the January 14, 2021 release date of firmware version 6.1.2. Note: If you do not have record of the firmware version installed on the LiNX Gyro Modules you have purchased from Invacare, you must connect to the LiNX system on the wheelchair using the LiNX Access tool to determine the firmware version of the Gyro
Recall details
- Recall number
- Z-0445-2022
- Status
- Open, Classified
- Initiated by the company
- Nov 12, 2021
- Recalling firm
- Invacare Corporation
- Quantity
- 1477 units US; 1226 units OUS
- Product code
- ITI
- FDA submissions
- K170507
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
10 devices in the FDA device registry whose identifier appears in the recall's code information.
- TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx TDXSP2-MCGInvacare Corporation · Wheelchair, powered2 recalls2 reports
- TDX SP2 with LiNX Electronics TDXSP2Invacare Corporation · Wheelchair, powered2 recalls0 reports
- Invacare® TDX SP2 with Captain's Seat TDXSP2VInvacare Corporation · Wheelchair, powered2 recalls0 reports
- TDX SP2 Base for Single Act. System w/Ultra Low Maxx TDXSP2-CGInvacare Corporation · Wheelchair, powered1 recall0 reports
- TDX SP2 Base for Single Act. System w/ Ultra Low Maxx TDXSP2X-CGInvacare Corporation · Wheelchair, powered1 recall0 reports
- TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx TDXSP2X-MCGInvacare Corporation · Wheelchair, powered1 recall0 reports
- Invacare® TDXSP2-HD with Captains Seat TDXSP2V-HDInvacare Corporation · Wheelchair, powered1 recall0 reports
- Invacare® TDXSP2 HD Power Wheelchair Base TDXSP2HDInvacare Corporation · Wheelchair, powered1 recall0 reports
- Invacare® TDXSP2 HD Base for Single Actuator System TDXSP2HD-CGInvacare Corporation · Wheelchair, powered1 recall0 reports
- Invacare® TDXSP2 HD Base for Multiple Actuator System TDXSP2HD-MCGInvacare Corporation · Wheelchair, powered1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89062).
- Z-0446-2022 · Open, ClassifiedInvacare 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-0447-2022 · Open, ClassifiedInvacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page