Events

Safety Alert for Breeze C Scooters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Afikim Electric Vehicles.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-10-02
  • Event Date Posted
    2013-10-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: afikim breeze c scooters the united states food and drug administration (fda) has issued a medical device safety alert concerning breeze c scooters, manufactured by afikim electric vehicles. the affected products are identified as follows:- serial no.: 10390024, 11390060, 11490426, 12390107, 12490181, 10390025, 11390061, 11490433, 12390117, 12490182, 10390029, 11390069, 11490435, 12390120, 12490183, 10390030, 11390074, 11490445, 12490169, 12490184, 10390034, 11390095, 12390096, 12490170, 12490185, 10390037, 11390101, 12390097, 12490172, 12490186, 10490100, 11490111, 12390098, 12490173, 12490187, 10490108, 11490147, 12390099, 12490174, 12490188, 10490111, 11490176, 12390101, 12490175, 12490189, 10490113, 11490189, 12390102, 12490176, 12490190, 10490119, 11490277, 12390103, 12490177, 12490191, 10490121, 11490304, 12390104, 12490178, 12490192, 10490124, 11490305, 12390105, 12490179, 12490193, 11390058, 11490425, 12390106, 12490180 the products were manufactured from 02/07/2010 to 24/07/2012 and distributed from 15/09/2010 to 25/07//2013. during product testing, the manufacturer became aware of a potential scenario where an internal potentiometer wiper could become disconnected due to extensive wear. if this were to occur the device could continue to drive forward at a slow speed of approximately 2-4 mph and the only way to stop the device would be by turning off the main key switch. there is no injuries have been reported to date. the manufacturer is notifying its distributors and customers by telephone and/or email and is arranging for correction of all affected products. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm370577.Htm http://www.Fda.Gov/safety/recalls/ucm370503.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

Breeze C Scooters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Afikim Breeze C Scooters
  • Manufacturer
    Afikim Electric Vehicles

Manufacturer

Afikim Electric Vehicles