FDA recall Z-1130-2022

Invacare Corporation · Class II · device

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-03-30
Report date
2022-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elyria, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1130-2022