Events

Alerta De Seguridad para sat 805 and sat 816 pulse oximeters

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

¿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
    2012-12-11
  • Fecha de publicación del evento
    2012-12-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121211a.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: bitmos sat 805 and sat 816 pulse oximeters the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning sat 805 and sat 816 pulse oximeters manufactured by bitmos. according to the manufacturer, the affected products may stop monitoring, providing dashes on the display and not providing an audible or visual notification to identify the change in state. the manufacturer advises the affected users to suspend the use of the products immediately and return the affected products for software update. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con213146 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

sat 805 and sat 816 pulse oximeters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Bitmos sat 805 and sat 816 pulse oximeters
  • Manufacturer
    Bitmos

Manufacturer

Bitmos