Recall Z-0115-2014— S.A.E. AFIKIM

Name: FDA recall Z-0115-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-27

Class II · Terminated

Class II FDA medical device recall by S.A.E. AFIKIM, initiated 2013-09-27, terminated 2014-07-23. It names one FDA 510(k) clearance: K102304. 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.. 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..

Recalling firm: S.A.E. AFIKIM
Classification: Class II
Status: Terminated
Initiated: 2013-09-27
Terminated: 2014-07-23
Firm location: Kibbutz Afikim, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K102304 — BREEZE C MODEL C (3W), BREEZE C (4W)Afikim Electric Vehicles·cleared 2011-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.