Events

Recall of Siemens Advia Centaur XPT System

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

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
    18832
  • Event Initiated Date
    2015-07-09
  • 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
    Siemens healthcare diagnostics has identified the following issue on the advia centaur® xpt system :, · the time of initiation for onboard stability (obs) on the advia centaur® xpt system is calculated when probe wash reagent packs are pierced (used by the system), not when loaded onto the instrument, for probe wash reagents pw2, pw3 and pw4., · because onboard stability (obs) is calculated when the probe wash reagent pack is pierced, not when loaded onto the instrument, the probe wash reagent pack may be on the instrument longer than described in the instructions for use (ifu).
  • Action
    Instructions for use to be updated

Device

Siemens Advia Centaur XPT System

Manufacturer

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