Invacare TDX SP2 with LiNX Gyro Power Wheelchair — Class II medical device recall Z-0445-2022
Ongoing recall by Invacare Corporation, reported 2022-01-12, distributed nationwide. Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive d
| Recall number | Z-0445-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invacare Corporation, Elyria, OH, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2022-01-03 |
| Reported by FDA | 2022-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ, TH |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00841447100911, 00841447100942, 00841447100966, 00841447101000, 00841447101017, 00841447101512, 00841447102052, 00841447108641, 00841447111207, 00841447111214 |
| Model numbers | DLX-GRY100-A, DLX-GRY101-A, SP2, TDXSP2, TDXSP2-CG, TDXSP2-MCG, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2X-CG, TDXSP2X-MCG |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0445-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.