Class 2 Device Recall Breeze C Scooter

• Date Initiated by Firm: September 27, 2013
• Date Posted: October 30, 2013
• Recall Status: Terminated on July 23, 2014
• Recall Number: Z-0115-2014
• Recall Event ID: 66410
• 510(K)Number: K102304
• Product Classification: Vehicle, motorized 3-wheeled - Product Code INI
• Product: 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 wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
• Code Information: Serial Numbers: 10390024, 10390025, 10390029, 10390030, 10390034, 10390037, 10490100, 10490108, 10490111, 10490113, 10490119, 10490121, 10490124, 11390058, 11390060, 11390061, 11390069, 11390074, 11390095, 11390101, 11490111, 11490147, 11490176, 11490189, 11490277, 11490304, 11490305, 11490425, 11490426, 11490433, 11490435, 11490445, 12390096, 12390097, 12390098, 12390099, 12390101, 12390102, 12390103, 12390104, 12390105, 12390106, 12390107, 12390117, 12390120, 12490169, 12490170, 12490172, 12490173, 12490174, 12490175, 12490176, 12490177, 12490178, 12490179, 12490180, 12490181, 12490182, 12490183, 12490184, 12490185, 12490186, 12490187, 12490188, 12490189, 12490190, 12490191, 12490192, and 12490193.
• Recalling Firm/ Manufacturer: S.A.E. AFIKIM; Kibbutz Afikem; Kibbutz Afikim Israel
• For Additional Information Contact: Ofer Amitay; 800-809-3010
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 Adverse Event Reporting program either by online, fax, or regular mail.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = INI