Events

Safety Alert for Digital Linear Accelerator

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

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
    2015-03-31
  • Event Date Posted
    2015-03-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150331.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 digital linear accelerator it has come to our attention that medical device manufacturer, elekta, has identified an unserviceable batch of bolts used to install the counterbalance weight assembly on the gantry drum of elekta digital linear accelerator [serial numbers: 152807, 152943, 153060, 153255, 153300, 153348 - 153350, 153359, 153406, 153511, 153530 - 153532, 153534 - 153586, 153588 - 153620, 153622 - 153647, 153649 - 153670, 153672 - 153678, 153680, 153683 - 153685, 153691, 153696, 153699, 153702, 153710, 153712, 153713, 153715, 153717, 153723 - 153728, 153734] the defective bolts have the mark “of” on the head. if the bolts have a fault, the gantry drum is not stable. it can fall and cause fatal injuries to users. the manufacturer will replace all the defective bolts that have the mark “of” on the head. the manufacturer advises users not to use the digital linear accelerator until the bolts are checked by the manufacturer’s representative. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 march 2015.

Device

Digital Linear Accelerator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta Digital Linear Accelerator
  • Manufacturer
    Elekta

Manufacturer

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