Events

Recall of Siemens syngo RT Dosimetrist

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
    16745
  • Event Initiated Date
    2014-05-27
  • 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
    Under special workflow conditions involving reloading data, a newly created structure is renamed incorrectly by the software as the name of the last deleted structure. if this incorrect structure is used for treatment planning, there is a potential that an incorrect target is treated. this issue is only unlikely to be detected if the incorrect structure is very similar to the correct structure. the probability of a severe mistreatment is practically impossible with good clinical practice, as considerable changes from the original treatment plan would be detected during the treatment planning and approval.
  • Action
    Software to be upgraded

Device

Siemens syngo RT Dosimetrist
  • Model / Serial
    Model: , Affected: , Software version: Version 2.7
  • Manufacturer
    Siemens AG

Manufacturer

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