Events

Recall of Siemens Artis Q, Q.zen, zeego, zee systems

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

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
    20952
  • Event Initiated Date
    2016-12-16
  • 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
    This corrective action addresses 2 possible, mutually independent causes of a system defect. in artis systems with a100plus or a100g generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator., for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.
  • Action
    Software to be upgraded

Device

Siemens Artis Q, Q.zen, zeego, zee systems
  • Model / Serial
    Model: , Affected: In Artis systems with A100Plus or A100G generators
  • Manufacturer
    Siemens Healthcare GmbH

Manufacturer

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