Events

Alerta De Seguridad para CyberKnife Treatment Delivery System

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

¿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
    2018-08-28
  • Fecha de publicación del evento
    2018-08-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180828.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: accuray cyberknife treatment delivery system medical device manufacturer, accuray, has issued a medical device safety alert concerning its cyberknife treatment delivery system. the manufacturer has discovered an issue related to specific batches of calibration film used with the ball-cube ii phantom in calibrating the cyberknife treatment delivery system (cyberknife system). the ball-cube ii phantom calibration film (ball-cube ii film) was not manufactured within necessary dimensions and may introduce up to 0.5mm of positional inaccuracy to the cyberknife system. this inaccuracy is within the 0.95mm specification for overall delivery accuracy of the cyberknife system. however, it is an additional source of error that when added to other sources of error may exceed the expected positional tolerance of the system. according to the manufacturer, only the ball-cube ii film manufactured from 1 august 2017 to 31 july 2018 and labeled with "ashland" are affected. most systems calibrated using the affected bait-cube ii film will still operate within the 0.95mm overall delivery accuracy. a small portion of systems may have up to a 1.45mm error in positional accuracy. the affected users are recommended to take the following actions to ensure cyberknife system positional accuracy is within specifications: stop using and quarantine the affected products. the new ball-cube ii film provided with the customer letter can be used to perform both a 6d skull and fiducial end-to-end test to preliminarily assess the positional inaccuracy. if the results do not meet the acceptance criteria, they should contact the manufacturer to schedule service. product removal and replacement are on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 august 2018.

Device

CyberKnife Treatment Delivery System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Accuray CyberKnife Treatment Delivery System
  • Manufacturer
    Accuray

Manufacturer

Accuray