Medical device recalls Moderate risk

TiSport, Llc recalls Permobil TiLite, Models: Aero Z, and ZRA

Recall date
September 24, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0264-2022
FDA classification
Class II
Brand / firm
TiSport, Llc
Sold / distributed
US Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL, CA, OH, KY, LA, OK, WI, TX, NC, SD, MN, MA, OR; OUS (Foreign): AUSTRALIA, CANADA, FRANCE, GERMANY, IRELAND, ITALY, UNITED KINGDOM, URUGUAY, NEW ZEALAND, IRELAND, SWEDEN

Why it was recalled

Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.

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

What was recalled

Permobil TiLite, Models: Aero Z, and ZRA

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