Events

Recall of Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option

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-00614-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00614-1
  • 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 became aware of an incident where a patient was pinched between the moving gantry and the tabletop during an auto-sequenced treatment. in this case, an automatic gantry movement during an auto-sequenced treatment led to the collision because: - the auto-sequenced treatment has been created including beams with table angles. and - no dry run has been performed. and - the therapist did not monitor the patient during treatment delivery.
  • Action
    Siemens is providing preventative work around instructions in its letter to customers, relating to beam placement, utilisation of dry runs after each change to the treatment plan, treatment interruption during patient repositioning, user care in field entries, patient monitoring and use of an optional inbuilt collision avoidance system such as ‘OPTIGARD’ if available. Additionally, therapist-identified potential collision between the gantry and the patient during use is preventable by the therapist by three separate button mechanisms. Siemens is also investigating a new method of determining whether there is a significant probability of collision between the LINAC gantry and the patient or the table.

Device

Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment ...
  • Model / Serial
    Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option Catalogue/Lot number: LINAC Systems (Material Numbers 4505200, 5857912, 7360717, 8139789) with SIMTECARTG Number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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