Invacare TDX SP2 Power Wheelchairs May Lose Power Due to Battery Harness Disconnection
Invacare TDX SP2 power wheelchairs may experience battery harness disconnection during shipment or use, resulting in loss of power. Approximately 133 affected devices have been distributed in the U.S. and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Class II FDA medical device recall for a documented mechanical defect that eliminates wheelchair functionality and creates risk of harm. However, no injuries or deaths have been reported in the source text, which per the rubric limits the score to 3 (High).
Plain-English summary
Invacare Corporation is recalling the TDX SP2 power wheelchair models TDXSP2, TDXSP2-MCG, and TDXSP2V. Approximately 133 units have been distributed nationwide across the United States and Canada.
The battery wiring harness on these wheelchairs may become disconnected during factory shipment or during normal use—particularly when traversing large obstacles or following jolts or impacts to the wheelchair. Disconnection of the harness results in complete loss of power to the wheelchair.
Users of affected wheelchairs should discontinue use and contact Invacare Corporation for inspection and repair of the battery harness.
The recalled product
- Product
- Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
- Manufacturer
- Invacare Corporation
- Affected units
- 133
Distribution
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