Medical device recalls Moderate risk

Invacare Corporation recalls Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

Recall date
March 30, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1130-2022
FDA classification
Class II
Brand / firm
Invacare Corporation
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of AK, AR, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, and WI. The country of Canada.

Why it was recalled

The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

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