Summary
The FDA issued a Class II for Permobil TiLite, Models: Aero Z, and ZRA by TiSport, Llc. 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.
Details
Source
Device Recall
External ID
Z-0264-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
Permobil TiLite, Models: Aero Z, and ZRA
Lot/Code Info: Manufactured between January 19, 2017 and June 14, 2021 with the serial number range from M2005054 to 1231112011
Quantity Affected: 5373
Reason for Recall
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-24
Company
Pasco, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TiSport, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TiSport, Llc have FDA actions?
This is the only FDA action we have on record for TiSport, Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0264-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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