Events

Alerte De Sécurité sur ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Varian Medical Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-10-07
  • Date de publication de l'événement
    2015-10-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151007a.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems