Events

Recall of Siemens AXIOM Artis X-ray system, handswitch

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
    16855
  • Event Initiated Date
    2014-06-18
  • 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
    There is a potential problem with axiom artis or artis zee system in connection with hand switch material number 3771750 operated at the patient table to release a x-ray image. the hand switch to release an x-ray image at the patient table is equipped with a cable extension inside the table. a problem may occur if the connection between cable connection and hand switch is contaminated with an extraordinary large amount of fluid. in a worst case situation, uncontrolled release of an x-ray image may happen. if this situation occurs, the system terminates uncontrolled x-ray after a short period.
  • Action
    Product to be modified

Device

Siemens AXIOM Artis X-ray system, handswitch
  • Model / Serial
    Model: Model: 3771750, Affected:
  • Manufacturer
    Siemens AG

Manufacturer

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