Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provi

FDA device recall Z-0115-2014 · posted 2013-10-30 · Terminated

Recall details

Recalling firm

S.A.E. AFIKIM

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

INI

Quantity affected

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, Tex

Date initiated

2013-09-27

Date posted

2013-10-30

Date terminated

2014-07-23

Location

Afikim, Israel

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