FDA-Device2021-11-24Class II
Permobil TiLite, Models: Aero Z, and ZRA
TiSport, Llc
Hazard
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.
Sold states
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
Affected count
5373
Manufactured in
2701 W Court St, N/A, Pasco, WA, United States
Products
Permobil TiLite, Models: Aero Z, and ZRA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2022Don't want to check this manually?
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