Events

Recall of ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty 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-2017-RN-00168-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00168-1
  • 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 have identified that incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide. this can happen if the slide, on which the sensors used to detect the rotational collimator position are mounted, is not in its fully latched position. if the user is not aware of the incorrect values the patient can be mistreated by dose at the wrong location.Siemens were also made aware of a defective weld seam at overhead suspensions. due to such a defect the weld seam might break and the overhead suspension might fall down. this can lead to a severe injury of the patient or any other person.
  • Action
    Siemens is undertaking hardware updates regarding the collimator position detection and improper weld seam at overhead suspensions. To keep the sensor slide in its latched position, a locking plate will be mounted to the sensor slide. This will significantly reduce the risk that the sensor slide might be mechanically misaligned and cause incorrect values being displayed for the rotational collimator position. As reinforcement, a bracket will be added to the overhead suspension to ensure the stability of the connection. This will prevent the overhead suspension from falling down.

Device

ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094
  • Model / Serial
    ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094ARTG Number: 165502
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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