Events

Safety Alert for Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.)

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
    2011-12-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111214a.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 precise digital accelerator, synergy platform, synergy, synergy s, infinity, axesse (various models, all lot no.) medical device manufacturer, elekta limited, has issued a field safety notice on precise digital accelerator, synergy platform, synergy, synergy s, infinity, axesse, linear accelerator systems. a small number of reverse modulator diodes, a component in the equipment room of the linear accelerator, have ruptured. customers have heard a loud explosion in the equipment room sometime after beam termination. the patient and clinical operators are not at risk. a service engineer, or any personnel entering the equipment room could sustain serious injury. elekta reported that no incidents involving personnel have occurred. elekta has communicated with the users about the fitting of a reverse diode cover and advised that personnel who enter the equipment room should wear protective safety glasses before the cover is fitted. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier.

Device

Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Mode...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.)
  • Manufacturer
    Elekta Limited

Manufacturer

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