Events

Recall of Siemens Artis zee Floorstand, Artis zee Biplane Floorstand, and Artis zee Multi Purpose X-Ray 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
    18629
  • Event Initiated Date
    2015-06-08
  • 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
    A possible position sensor fault in the swivel base axis not being detected by the system software may cause the c-arm system to move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision.
  • Action
    Software to be upgraded

Device

Siemens Artis zee Floorstand, Artis zee Biplane Floorstand, and Artis zee Multi Purpose X-Ray sys...
  • Model / Serial
    Model: 10094135, 10094141, 10094139, Affected: Version VC21B
  • Manufacturer
    Siemens AG

Manufacturer

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