Events

Alerta De Seguridad para allura xper fd10/10

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

¿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
    2013-06-25
  • Fecha de publicación del evento
    2013-06-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130625.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: philips allura xper fd10/10 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning allura xper fd10/10, which is a biplane cardiovascular x-ray system manufactured by philips. all systems are affected. the medical device alert mentions that the table will reboot if users attempt a powered and manual movement at the same time. the reboot will take approximately 90 seconds during which time no motorised movement will be possible. this has led to delay during emergency treatment. basic imaging will still be available. the mhra reminds the superintendent diagnostic radiographers to identify the affected devices and inform users of the issue. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/ con286972 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 june 2013.

Device

allura xper fd10/10
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Allura Xper FD10/10
  • Manufacturer
    Philips

Manufacturer

Philips
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH