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Recall Observatory FDA recall evidence

Device 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

Z-0447-2022

November 12, 2021

Class II

Product summary

Firm
Invacare Corporation
Event
Event 89062
Status
Ongoing
Classification
Class II
Quantity
1 unit US
Official record key
device-enforcement:Z-0447-2022

Official wording

Reason: 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

Code information: LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: SRX-20MP 00841447114581 SRX-20R 00841447114604 SRX-20SP 00841447114598

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware version 6.1.2 can