Events

Recall of Siemens Artiste syngo RT Therapist (RTT) Software

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Siemens AG.

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
    16028
  • Event Initiated Date
    2014-01-13
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    There is a potential safety issue when using the "in-session resumption" feature of the syngo rt therapist 4.3 software. this feature allows for one or more partially delivered beams to be re-delivered to make up for the deficit in total monitor units (mu) planned for delivery., in a rare scenario in which several conditions are fulfilled, the system will send the already treated beam again to the control console of the linear accelerator for full delivery. this will result in a greater dose being delivered than was planned.
  • Action
    Software to be upgraded

Device

Siemens Artiste syngo RT Therapist (RTT) Software
  • Model / Serial
    Model: , Affected: , Software version: Version 4.3
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA