Events

Alerta De Seguridad para Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Chien Ti Enterprise Co..

¿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
    2012-02-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120206.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
    Field safety notice: leo 3-wheel scooter and leo scooter, model # leo-4b the food and drug administration (fda), united states, has issued a class ii recall on leo 3-wheel scooter and leo scooter, model # leo-4b, manufactured by chien ti enterprise co., ltd. according to the distributor, invacare corporations, the products are being recall because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the fda website: http://www.Fda.Gov/safety/recalls/enforcementreports/ ucm290086.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B
  • Manufacturer
    Chien Ti Enterprise Co.

Manufacturer

Chien Ti Enterprise Co.