Events

Safety Alert for XVI R4.5 systems

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

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
    2012-05-03
  • Event Date Posted
    2012-05-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120503d.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: elekta xvi r4.5 systems medical device manufacturer, elekta limited, has issued a field safety notice concerning all xvi r4.5 systems. elekta recommended a mandatory software upgrade to all xvi r4.5 systems. the upgrade corrects the problem that prevents the operation of the database reindex function and prevents the error that incorrectly causes a kv gating inhibit during a segmental volumeview™. according to the local supplier, the affected system has been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 03 may 2012.

Device

XVI R4.5 systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta XVI R4.5 systems
  • Manufacturer
    Elekta Limited

Manufacturer

Elekta Limited
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DH