Alerta De Seguridad para Puma, Beatle, Alex and Ibis XP power wheelchairs

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

¿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
    2011-11-15
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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
    Mhra field safety notice: handicare puma, beatle, alex and ibis xp power wheelchairs the medicines and healthcare products regulatory agency (mhra) has issued a safety notice concerning the compact lights on puma, beatle, alex and ibis xp power wheelchairs manufactured by handicare ltd. handicare explained that the lights might cause overheating and, as a result, parts of the compact lights unit could melt or, in extreme situations, ignite. handicare is now replacing the lights in the compact lights unit by new led lights. this precautionary action will affect puma, beatle, alex and ibis xp power wheelchairs equipped with compact light units sold from november 2003 up to and including september 2011. according to the manufacturer, the majority of the affected products were distributed to the netherlands and also to canada and some european countries. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Handicare Puma, Beatle, Alex and Ibis XP power wheelchairs
  • Manufacturer

Manufacturer

  • Source
    DH