Events

Recall of Siemens syngo CT 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
    15857
  • Event Initiated Date
    2013-12-11
  • 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
    If the function "auto save last displayed images as key images" is activated during an interventional procedure, the software configuration allows conflicting access to the ct system image database. in such situations a system display freeze might occur. normal interaction with the system is then no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognize the malfunction and continue the interventional procedure.
  • Action
    Software to be upgraded

Device

Siemens syngo CT Software
  • Model / Serial
    Model: , Affected: , Software version: Syngo version CT2012B and CT2013B
  • Manufacturer
    Siemens AG

Manufacturer

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