The Recall Desk
HighFDA (Devices)·Z-0446-2022·Announced 2022-01-12

Invacare AVIVA FX power wheelchair LiNX Gyro deceleration malfunction

Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The hazard—a firmware defect causing more aggressive deceleration than programmed—poses a significant risk of harm to power wheelchair users who may experience unexpected loss of control.

Plain-English summary

Invacare Corporation is recalling AVIVA FX power wheelchairs equipped with the LiNX Gyro module, models IFX-20R, IFX-20SP, IFX-20MP, and IFX-20C with LiNX Gyro firmware version 6.1.2.

The wheelchairs can experience a more aggressive deceleration rate than programmed due to the system following an incorrect deceleration profile. This malfunction can result in potential injury to users.

Approximately 303 units were distributed in the United States and 20 units distributed internationally to Canada, Australia, Thailand, and New Zealand. Consumers who own affected wheelchairs should contact Invacare Corporation for information about corrective action, such as a firmware update.

The recalled product

Product
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
Manufacturer
Invacare Corporation
Category
Medical Device — Power Wheelchair
Hazard
  • deceleration-malfunction
  • loss-of-control-risk
  • firmware-defect

Distribution

Distributed nationwide across the United States.

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