Events

Recall of Digital Linear Accelerators of type Primus, ONCOR and ARTISTE running Control Console software version 12.0.25 or 13.0.65 and syngo RT Therapist running software version 4.2.110 or 4.3.SP1

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-2016-RN-01086-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01086-1
  • 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 are advising users regarding a bundled update of the syngo rt therapist software and the control console software. the update addresses the following issues;- prevention from automatic movements in case of significant risk of collision- re-positioning of 160 mlc after motion stop interlock- restart of control console- support of fractional monitor units for virtual wedge- lost information after plan uid change in oncology information system (ois)- incorrect offset calculation in advanced targeting option- interrupt cone beam reconstruction- table rotation values for relative set up- wrong in-session resumption in case of 0 delivered monitor units- unexpected table movements after internal error message - dose linearity qa procedure for imrt- configuration of auto sequence for bolus fields- workflow information for moving patient for treatment from one machine to another.
  • Action
    These updates provide the corrections for previous recalls, with TGA Refs RC-2014-RN-00614-1, RC-2011-RN-00491-3 and RC-2012-RN-00592-3. The interim instructions are included in the previous recalls and include an update to the Instructions for Use (IFU) and work around instructions. A software upgrade will be implemented as a permanent correction. This action has been closed out on 16 June 2017.

Device

Digital Linear Accelerators of type Primus, ONCOR and ARTISTE running Control Console software ve...
  • Model / Serial
    Digital Linear Accelerators of type Primus, ONCOR and ARTISTE running Control Console software version 12.0.25 or 13.0.65 and syngo RT Therapist running software version 4.2.110 or 4.3.SP1 ARTG Number : 171515
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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