Power wheelchairs with LiNX Gyro module recalled for deceleration control failure
Invacare power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.
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 with no reported injuries or illnesses. The hazard—a firmware defect causing incorrect deceleration—presents a concrete risk of harm to wheelchair users, meeting the criterion for high severity when injury has not yet been reported.
Plain-English summary
Invacare is recalling TDX SP2 power wheelchairs equipped with the LiNX Gyro module running firmware version 6.1.2. The affected wheelchair models include TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, and TDXSP2HD-MCG. A total of 1,477 units were distributed in the United States and 1,226 units were distributed internationally in Canada, Australia, Thailand, and New Zealand.
The recalled wheelchairs can experience more aggressive deceleration than the programmed rate. The LiNX Gyro system follows an incorrect deceleration profile, which reduces the wheelchair's braking control. This malfunction may cause sudden, unexpected deceleration and loss of control, potentially resulting in user injury.
The recalled product
- 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
- Manufacturer
- Invacare Corporation
- Hazard
- firmware-defect
- deceleration-failure
- loss-of-control
Distribution
Distributed nationwide across the United States.
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