FDA-Device2022-06-01Class II
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Invacare Corporation
Hazard
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.
Sold states
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.
Affected count
133 devices
Manufactured in
1200 Taylor St, Elyria, OH, United States
Products
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2022Don't want to check this manually?
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