Events

Alerta De Seguridad para Pinnacle3 Radiation Treatment Planning System

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
    2014-08-08
  • Fecha de publicación del evento
    2014-08-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140808.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 healthcare pinnacle3 radiation treatment planning system medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning its pinnacle3 radiation treatment planning system with software version 9 0, 9 2 9 4, and 9 6. the issue occurs under certain specific conditions where the user modifies a contour in a density-overridden roi (region of interest with density set to a specific value) in a computed plan. dose is subsequently invalidated and the user may recompute the dose. in this case, the density can be replaced by the ct number from the ct to density table when recomputed resulting in an incorrect dose and the monitor units (mu) may then be much higher than originally planned. the user may continue, and save the plan with incorrect dose. when reopening the plan, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density. this issue could create an incorrect mu calculation, resulting in an incorrect dose to the target or other structures. if the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.¬ the manufacturer will upgrade all the affected units to version 9.8 and it recommends users to always use version 9.8 or above for patient planning. if users do not have version 9.8 installed, they should contact local representative. furthermore, the fsn should be placed in instructions for use until otherwise notified. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 aug 2014.

Device

Pinnacle3 Radiation Treatment Planning System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Healthcare Pinnacle3 Radiation Treatment Planning System
  • Manufacturer
    Philips Healthcare

Manufacturer

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