Events

Recall of Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302

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-00284-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00284-1
  • 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 identified a risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table using the simtec auto field sequence option. the following issues will be addressed in the software update solution "auto field sequence (afs) motion protection”:- risk of collision due to automatic gantry movements in case of lateral table shifts and- unwanted automatic gantry movements in case of table configuration set to “manually” and the movement order to be “table first”.
  • Action
    Siemens is advising affected users to be aware of the updated software solution “Auto Field Sequence (AFS) Motion Protection” which will be implemented at the Control Console of their Digital Linear Accelerator. This software will not execute a movement if a potential collision is anticipated and that users may, in such cases, perform the planned movement manually. Users are further advised that despite these safety measures, there might be scenarios which are not covered by the software. Therefore, during an auto-sequence delivery, users must be aware, at all times, of any movement of the gantry, the treatment table and the applied table offsets or overrides according to the treatment plan.

Device

Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13...
  • Model / Serial
    Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302ARTG Number: 165502
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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