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AFIKIM Oct-30-2013 Breeze C Scooter – Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze; model C. Bipolar Maryland and curved needle Driver; were.

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Class 2 Device Recall Breeze C Scooter
Date Initiated by FirmSeptember 27, 2013
Date PostedOctober 30, 2013
Recall Status1Terminated 3 on July 23, 2014
Z-0115-2014
Recall Event ID66410
K102304
Vehicle, motorized 3-wheeled - Product CodeINI
ProductBreeze 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 InformationSerial 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 ContactOfer Amitay
800-809-3010
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.
Process control
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.
69 units
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.
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) Database510(K)s with Product Code = INI and Original Applicant = AFIKIM ELECTRIC VEHICLES
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S.a.e Afikim Drivers License

  1. The drivers of this change are many and include the massive increase in technologies to aid in dairy cow reproductive management, quota removal (within Europe) and the significant increase in herd / farm size. Afikim, Kibbutz Afikim, Israel), whereas the use of a neck collar (e.g., Alpro; DeLaval International AB, Tumba.
  2. Afikim: Vehicle for invalids EP0403977A3 (en). 1989-06-18: 1991-06-05: S.A.E. Afikim: Vehicle for invalids US5695021A (en). 1993-11-12: 1997-12-09: Pride Health Care, Inc. Electrically-powered scooter for personal transport US5806622A (en). 1996-04-24: 1998-09-15: Nev Corporation.