Events

Recall of MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-01358-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01358-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Siemens has received reports of one circuit board (g41) located inside of the linac gantry showing signs of overheating. after a detailed analysis the root cause was found to be one of the components that belong to this board (head driver pcb). siemens has redesigned the head driver pcb to further mitigate the risk of local overheating on the g41 motherboard.
  • Action
    Siemens has redesigned the Head Driver PCB to further mitigate the risk of local overheating on the G41 motherboard. The present corrective action comprises the replacement of the Head Driver PCB by a redesigned component on your LINAC. This action has been closed-out on 12/08/2016.

Device

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codes
  • Model / Serial
    MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators Multiple product codesAll serial numbersARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA