Recall Z-0264-2022 ยท IOR Wheelchair, Mechanical
TiSport, Llc
Permobil TiLite, Models: Aero Z, and ZRA
| Date | Sep 24, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component change control |
| Action | On 09/24/21, distribution of correction notices started, via mail, to distributors. Distributors were advised the following: For AERO Z wheelchairs, the transit tie downs should have an inward orientation with transit bracket in rear most position. The wheelchair provider was provided with clear and thorough work instructions on how to inspect and, when necessary, correctly configure the transit tie downs. Stop using TiLite ZRA with transit tie downs as a passenger seat in a motor vehicle. Remove transit tie downs on TiLite ZRA wheelchairs. The recalling firm, if requested, will supply at no c |
| Quantity | 5373 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990358 | CROSS SPORT, RIGID WHEELCHAIR Tisport, Feb 26, 1999 |