Events

Alerta De Seguridad para Pinnacle3 software

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

¿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
    2013-05-08
  • Fecha de publicación del evento
    2013-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508c.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 pinnacle3 software medical device manufacturer, philips healthcare issued a field safety notice concerning all pinnacle3 software with versions 9, 9.2, and 9.4. a problem has been detected in the philips pinnacle3 software that, if it were to re-occur, could affect the performance of the equipment. under certain conditions in pinnacle3 9, 9.2, and 9.4, users can modify the geometry of a beam or change the parameters for a bolus and the software does not invalidate the control point dose. philips healthcare is distributing an addendum to the pinnacle3 instructions for use (ifu) which describes how to explicitly invalidate control point dose in this situation. the underlying issue is corrected in pinnacle3 9.6. the manufacturer recommends customers to review the information contained in the notice including the ifu addendum with all members of the staff who need to be aware of their contents and retain a copy of the addendum with the pinnacle3 9, 9.2, and 9.4 ifu. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Pinnacle3 software
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Pinnacle3 software
  • Manufacturer
    Philips Healthcare

Manufacturer

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