Events

Recall of Siemens Wireless Footswitch

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
    21168
  • Event Initiated Date
    2017-03-02
  • 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 gap in the housing of the wireless foot switch can result in liquids penetrating the interior and can in rare cases result in the failure of the foot switch. if the foot switch fails, it will no longer be possible to use it to release radiation. the hand switch provided can still be used to release exposures, but fluoroscopic examinations will not be possible.
  • Action
    Instructions for use to be updated

Device

Siemens Wireless Footswitch
  • Model / Serial
    Model: , Affected: Catalogue number 4787797, 4787805, 4787813
  • Manufacturer
    Siemens AG

Manufacturer

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