The Recall Desk
HighFDA (Devices)·Z-0447-2022·Announced 2022-01-12

Invacare AVIVA Storm RX Power Wheelchairs Recalled for Firmware Deceleration Malfunction

Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.

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 medical device recall for a power wheelchair malfunction that creates a risk of harm through aggressive deceleration. No injuries have been reported, but the defect presents a clear potential for user injury, meeting the criteria for High-severity classification.

Plain-English summary

Invacare Corporation is recalling AVIVA Storm RX power wheelchairs equipped with the LiNX Gyro module. The recalled models are SRX-20R, SRX-20SP, and SRX-20MP with firmware version 6.1.2. The wheelchairs can experience more aggressive deceleration than the programmed rate because the system follows an incorrect deceleration profile. This malfunction could result in potential injury to users.

The affected wheelchairs have been distributed worldwide, including the United States, Canada, Australia, Thailand, and New Zealand.

The recalled product

Product
Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
Manufacturer
Invacare Corporation
Category
Medical Device — Mobility / Power Wheelchair
Hazard
  • aggressive-deceleration
  • malfunction

Distribution

Distributed nationwide across the United States.

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