Events

Alerta De Seguridad para Ingenuity Core

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
    2018-04-16
  • Fecha de publicación del evento
    2018-04-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180416.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 ingenuity core the therapeutic goods administration (tga), australia posted a medical device safety alert concerning philips ingenuity core [model number: 728321; serial number: 333175]. the manufacturer has identified systems that may have been infected with the "wannacry" ransomware virus before installation. the virus may encrypt files in a way that: prevents system access; or a patient undergoing a scan or recently scanned whose results have not been reviewed may require a ct rescan; or during a biopsy the system may be slowed such that the operator is unable to visualise the advancement of a biopsy needle in real time. according to the manufacturer, there have been no reports of patient harm as a result of this issue. the manufacturer will contact the users to arrange an appointment for a field service engineer to correct the software on any potentially impacted systems for details, please visit the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00312-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2018.

Device

Ingenuity Core
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Ingenuity Core
  • Manufacturer
    Philips

Manufacturer

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