Home / Recalls / Invacare Corporation / Z-0445-2022

Z-0445-2022 Class II Ongoing

Recalled by Invacare Corporation — Elyria, OH

Recall Details

Product Type
Devices
Report Date
January 12, 2022
Initiation Date
November 12, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1477 units US; 1226 units OUS

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

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

Distribution Pattern

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

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

Other recalls by Invacare Corporation

  • Z-1251-2024 Class II — Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Mo (January 22, 2024)
  • Z-2445-2023 Class II — DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve (June 15, 2023)
  • Z-1369-2022 Class III — Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canad (June 10, 2022)
  • Z-1130-2022 Class II — Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V (March 30, 2022)
  • Z-0447-2022 Class II — Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module M (November 12, 2021)
  • Z-0446-2022 Class II — Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model (November 12, 2021)
  • Z-0514-2021 Class II — Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory (October 30, 2020)
  • Z-0549-2019 Class II — Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P Th (November 16, 2018)
  • Z-2218-2017 Class II — Assist Bed Rail - 6632 (April 25, 2017)
  • Z-1183-2017 Class II — Bariatric Bed - BARPKG-IVC 1633 (December 2, 2016)