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
    18834
  • 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 has identified a number of workflow issues with advia centaur xpt system software v1.0.1 and v1.0.2:, * the system does not display any indication of a missing required probe wash pack on the results screen., * the data shown on the "utilities->assay utilization" screen is incorrect for the totals of calibrators run on the instrument, * the data shown on the "utilities->assay utilization" screen and the printout report for assay utiliization may not match, the following issues are related to instruments connected to a lab automation system (las):, * if the instrument receives work orders while transition from the in-process state to the ready state, the sample will be routed to the instrument but may not be processed, *the system may stop processing samples from the las and hold a tube at the las sampling station.
  • Action
    Software to be upgraded

Device

Siemens Advia Centaur XPT System

Manufacturer

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