Events

Alerta De Seguridad para BIOS Rollator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Thermor 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
    2012-03-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120309c.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: bios rollator the health canada has issued a type i recall regarding the bios rollator (model 56001, serial number 1110-13870) manufactured by thermor ltd. the manufacturer received a complaint that a customer suffered a minor fall which resulted in very minor injury while using the device. investigation revealed that the problem was due to manufacturing defect which could result in the fracturing of metal welds. the manufacturer advised customers to stop using the product for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/ahc-asc/media/advisories-avis/_2012/2012_31-eng.Php if you are in possession of the product, please contact your supplier for necessary actions.

Device

BIOS Rollator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BIOS Rollator
  • Manufacturer
    Thermor Ltd

Manufacturer

Thermor Ltd