Events

Recall of Siemens Artis Systems

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
    18828
  • Event Initiated Date
    2015-07-13
  • 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
    Artis system has an x-ray locking function that prevents any accidental release of radiation. in case a system error occurs and the system enters the 'bypass fluoro' mode while the x-ray locking function is active, it won't be possible to exit the x-ray locking function. the only way to exit the x-ray locking function would be to either resolve the root cause of the system being in 'bypass fluoro' or to restart the system. in the situation described, no radiation is possible, no fluoroscopic images can be acquired.
  • Action
    Software to be upgraded

Device

Siemens Artis Systems
  • Model / Serial
    Model: All Artis models, Affected: SW Ver VC14J
  • Manufacturer
    Siemens AG

Manufacturer

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