Recall Z-0115-2014 ยท INI Vehicle, Motorized 3-Wheeled
S.A.E. AFIKIM
Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two whe
| Date | Oct 30, 2013 (initiated Sep 27, 2013) |
| Status | Terminated |
| Reason | Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key. |
| Root cause | Process control |
| Action | Afikim Electric Vehicles sent an URGENT: MEDICAL DEVICE RECALL letter, dated September 27, 2013, to all affected customers and distributors. . Customers are advised to remove the ignition key and contact Afikim Electric Vehicles via telephone Monday through Friday at 1-800-809-3010 between the hours of 9AM and 5PM (EST). Consumers may also contact the company via e-mail at dov@afiscooters.com. Customers are instructed to return the Recall Response Form by fax it to 800-466-1171 or email to ofer@afiscooters.com. Consumers should report any adverse event or quality problems to FDA's MedWatch |
| Quantity | 69 units |
| Distribution | Nationwide Distribution: US including the states of California, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102304 | BREEZE C MODEL C (3W), BREEZE C (4W) Afikim Electric Vehicles, Jan 7, 2011 |