Recall of Siemens Artis Zeego X-ray System with Software Artis

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
    14315
  • Event Initiated Date
    2013-03-08
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • 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
    The manufacturer advises that under certain preconditions, executing roadmap ogp (organ program) in the dsa overlay mode may lead to imprecise registration of the dsa mask image with the roadmap image displayed on the live monitor.
  • Action
    Software to be upgraded

Device

  • Model / Serial
    Model: , Affected: Software Artis VC20x/VC21A/VD10x that have a DSA license installed
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA