FDA recall Z-0445-2022

Invacare Corporation · Class II · device

Product

Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

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.

Key facts

Status: Ongoing
Initiation date: 2021-11-12
Report date: 2022-01-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Elyria, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0445-2022