Events

Safety Alert for ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Varian Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-10-07
  • Event Date Posted
    2015-10-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151007a.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems