Events

Alerta De Seguridad para Breeze C Scooters

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Afikim Electric Vehicles.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-10-02
  • Fecha de publicación del evento
    2013-10-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Afikim Breeze C Scooters
  • Manufacturer
    Afikim Electric Vehicles

Manufacturer

Afikim Electric Vehicles