Events

Recall of MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators

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-2013-RN-00585-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00585-1
  • 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
    It has come to the attention of siemens that one of their customers used film mode for image acquisition although it was not correctly calibrated, resulting in an overdose to several patients. film mode is a separate beam (dose set 8) and needs to be calibrated and verified prior to being used.
  • Action
    Siemens is providing additional calibration procedures and asking customers to make sure it is implemented. The physicist responsible for the system has to verify necessary system dosimetry for all beams used for patient treatment and imaging, in particular following a service intervention. Additionally, the necessary departmental QA procedures need to be followed. Siemens will also distribute information provided in the customer letter as an addendum to the user documentation.

Device

MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • Model / Serial
    MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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