Events

Safety Alert for Elekta XVI 4.5 and 4.6

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

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
    2011-10-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111019.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
    Field safety notice: elekta xvi 4.5 and 4.6 medical device supplier, elekta ltd, issued an important notice to bring users attention to certain precautionary measures required for the operation of elekta xvi. xvi dual registration can inform customers if an organ at risk has moved in relation to the target since the planning stage of treatment. it was discovered at customer site that there is a software error leading to compromise of the dual registration, and this issue applies to release 4.5 and 4.6. an important notice a357 was sent out to all xvi 4.5 and 4.6 users. the notice informs customers using dual registration with compromise how to recognize the issue and avoid it. a later software release of xvi will give a solution to this problem. according to the local supplier, the affected products have been distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Elekta XVI 4.5 and 4.6
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta XVI 4.5 and 4.6
  • Manufacturer
    Elekta Ltd

Manufacturer

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