Recall Z-0774-2012 ยท INI Vehicle, Motorized 3-Wheeled
Invacare Corporation
Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.
| Date | Jan 17, 2012 (initiated Dec 7, 2011) |
| Status | Terminated |
| Reason | Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury. |
| Root cause | Device Design |
| Action | On 12/7/2011 the firm sent Urgent: Recall Information Letters to their customers. The letter informed customers of the affected product and the related problem. The letter also states that Invacare has developed replacement seat kits intended to replace the original seats. The replacement kit will be provided free of charge and can be ordered by completing and returning the attached response card. After receiving replacement kits, customers are asked to contact their customers that have potentially affected devices and replace the seats immediately. Questions should be directed to Custome |
| Quantity | 391 scooters |
| Distribution | Worldwide Distribution -- USA, including the states of AK, CA, FL, GA, HI, IA, ID, IL, KS, LA, MD, MI, MN, MO, MT, NC, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, & WI, and the countries of AUSTRIA, BELGIUM, CZECH REPUBLIC, ESTONIA, FRANCE, GERMANY, IRELAND, ITALY, JERSEY (CHANNEL ISLANDS), LITHUANIA, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090735 | C.T.M. MOBILITY SCOOTER, HS-528 C.T.M. Homecare Product, Inc., Jul 6, 2009 |