Events

Alerta De Seguridad para ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology

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

¿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
    2015-10-07
  • Fecha de publicación del evento
    2015-10-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151007a.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: varian aria for radiation oncology, aria oncology information system for radiation oncology medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its aria for radiation oncology, aria oncology information system for radiation oncology [versions 10.X, 11.X, 13.0 or 13.5 with clinical assessment license only]. the manufacturer has identified an anomaly with the aria for radiation oncology software with a clinical assessment license. admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription “type” field after inputting admin instructions in the text box, the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions. the printed prescription will also not contain the intended admin instructions. hence, the pharmacy will not receive the administration information intended by the physician. the manufacturer has not received any reports of patient injury due to this issue. the manufacturer has provided instructions to affected users and is developing a technical correction for this issue. 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 7 october 2015.

Device

ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems