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
Product summary
- 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
firmware version 6.1.2 can