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

Invacare Corporation: Invacare 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

Is my product affected?

Invacare 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

  • UPC 00841447111627
  • UPC 00841447111658
  • UPC 00841447111634
  • UPC 00841447111641

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

What happened

Invacare Corporation is recalling Invacare AVIVA FX with LiNX Gyro Power Wheelchairs in models IFX-20R, IFX-20SP, IFX-20MP, and IFX-20C. The wheelchairs with LiNX Gyro components running firmware version 6.1.2 can experience deceleration rates that are more aggressive than programmed because the system follows an incorrect deceleration profile. This malfunction could result in potential injury to users.

The recalled wheelchairs were distributed worldwide, including throughout the United States and in Canada, Australia, Thailand, and New Zealand. A total of 303 units were distributed in the US and 20 units outside the US. The source document does not specify a remedy or corrective action 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: 303 units US; 20 units OUS Lot/code info: LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658

Source

Official record: FDA (Device enforcement) ↗

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

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