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FDA Medical Device Recalls (openFDA)

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 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.

Recall number
Z-0115-2014
Recalling firm
S.A.E. AFIKIM
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.
Status
Terminated
Initiated
2013-09-27
Posted
2013-10-30
Terminated
2014-07-23
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 Adverse Event Reporting program either by online, fax, or regular mail.
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.
Lot, serial or model codes
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.
510(k) numbers
["K102304"]
PMA numbers
not on file
Product code
INI
Firm FEI
1000646143
Firm city
Afikim
Firm state
not on file
Firm country
Israel

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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