Events

Recall of Siemens Advia Centaur XPT

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
    19549
  • Event Initiated Date
    2015-12-10
  • 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, 55 Hugo Johnston Drive, Penrose, Auckland
  • Reason
    Siemens healthcare has identified several issues with specific versions of the advia centaur xpt system software that may affect the operation and workflow of the system., issues include, * using the replicates option with the final result rule, * delta check units, * units on the calibration data details report, * using the copy configuration utility, * printer driver resets, * calibrating tsto, * laboratory automation (las) offline due to vacuum error, * monitoring the laboratory automation (las) communication, * priming needed error reported to las, * sample status reported to las, * non-siemens las - general status message, * non-siemens las - immediate index, * using dilution for automated repeats, * printing of results for replicates, * workstation services may restart, * rinse system maintenance task, * on board stability (obs) for hbsii, * enhance liver fibrosis (elf) test results, * archiving and deletion may fail, * processing repeats with multiple reagent lots.
  • Action
    Software to be upgraded

Device

Siemens Advia Centaur XPT

Manufacturer

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