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FDA (Device enforcement)Recalled 2021-11-12class ii

Invacare Corporation: 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, T

Is my product affected?

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

  • UPC 00841447100911
  • UPC 00841447100942
  • UPC 00841447100966
  • UPC 00841447108641
  • UPC 00841447111207
  • UPC 00841447111214
  • UPC 00841447101512
  • UPC 00841447102052
  • UPC 00841447101000
  • UPC 00841447101017

Check against the official notice below — it lists the full affected range.

What happened

Invacare Corporation has recalled Invacare TDX SP2 power wheelchairs equipped with a LiNX Gyro component running firmware version 6.1.2. The wheelchairs can experience a more aggressive deceleration rate than programmed because the system follows an incorrect deceleration profile, which could result in injury to users. The recall affects 1,477 units in the United States and 1,226 units in Canada, Australia, Thailand, and New Zealand.

The specific wheelchair models affected include TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG, TDXSP2V, TDXSP2V-HD, and TDXSP2X-MCG. The recall notice does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand. Quantity: 1477 units US; 1226 units OUS Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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