Events

Recall of 550 TxT Treatment Table used with 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-2014-RN-00157-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00157-1
  • 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 siemens attention that it is possible for patients or operators to have their fingers trapped and pinched between the table top and the bottom frame of the 550 txt treatment table.Secondly the manufacturer has received a report on an incident in which a cable inside the 550 txt treatment table has been damaged due to contacting a moving part. this resulted in a short circuit which overheated an electronic circuit board inside the table base.
  • Action
    Siemens is advising users that the affected treatment tables will be modified to increase the gap between the table top and the base frame to more than 25mm to prevent fingers being trapped or pinched. Siemens will also be modifying the cable routing inside the patient table base in order to ensure the affected cable cannot contact moving parts.

Device

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • Model / Serial
    550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear AcceleratorsCatalogue number: 7346534ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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