Events

Retiro De Equipo (Recall) de ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions10.X, 11.X, 13.0 or 13.5 with Clinical Assessment licence only

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Varian Medical Systems Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00988-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-10-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00988-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    An anomaly that has been identified 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. there have not been any reports of patient injury due to this issue.
  • Acción
    Varian is contacting all customers potentially affected by this anomaly with the temporary workaround and will provide regular reports to listing the potentially affected prescriptions. This documentation will be provided to the customer until a verified solution has been installed. Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service Representative when this correction is available to schedule its installation.

Device

ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions...
  • Modelo / Serial
    ARIA for Radiation Oncology and ARIA Oncology Information System for Radiation Oncology, Versions10.X, 11.X, 13.0 or 13.5 with Clinical Assessment licence onlySerial Numbers: HIT0739M, HIT0968, HIT1044, HIT1172M, HIT1390, HIT1421, HIT1599M, HIT1649, HIT2083, HIT2129M, HIT2263M, HIT2535, HIT2620, HIT2724, HIT3692, HIT3700, HIT4526M, HIT4909ARTG Number: 132638
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd