Events

Rappel 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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Varian Medical Systems Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00988-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-10-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00988-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd