Events

Safety Alert for C-Series Clinac, version 2.x through 6.x

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

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
    2014-04-14
  • Event Date Posted
    2014-04-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140414.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 c-series clinac, version 2.X through 6.X medical device manufacturer, varian, has issued a medical device safety alert concerning c-series clinac accelerators equipped with software versions 2.X through 6.X. the affected models are 600c, 600cd, 6ex, dbx, 2100c, 2100cd, 2300cd, 21ex, 23ex, dmx and dhx. according to the manufacturer, an event has been reported involving a c-series clinac accelerator. the event entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. the manufacturer advises users to take adequate precautions and exercise due care in aspects of position readout accuracy with c-series clinac accelerators equipped with the affected software versions. this does not affect the multileaf collimator (mlc). according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 april 2014.

Device

C-Series Clinac, version 2.x through 6.x
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Varian C-Series Clinac, version 2.x through 6.x
  • Manufacturer
    Varian

Manufacturer

Varian