Alerta De Seguridad para s5/s5i/CORE/CORE Mobile systems

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

¿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
    2016-05-10
  • Fecha de publicación del evento
    2016-05-10
  • 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
    Medical device safety alert: volcano s5/s5i/core/core mobile systems medical device manufacturer, volcano, has issued a field safety notice concerning its s5/s5i/core/core mobile systems. the affected software versions are v3.2.X, v3.3 and v3.4. the manufacturer has become aware of a system incompatibility issue between the affected systems and hospital network scans. in specific circumstances, the affected system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. this condition can occur at any time, including in the middle of a patient procedure. if this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of ivus and ffr/ifr functionality in the procedure. the manufacturer advises users of the following: disconnect the affected system from the facilities network. if users need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; or do not perform network scans while the affected system is in operation. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 may 2016.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Volcano s5/s5i/CORE/CORE Mobile systems
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH