Events

Recall of ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

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
    RC-2016-RN-00837-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00837-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Siemens has determined that certain waste reservoirs in advia centaur xpt system were manufactured with walls that are below the nominal specification, potentially causing the following problem when the reservoir is under vacuum: - the seam at the bottom of certain reservoirs could crack slightly and have a slight leak.- the fitting at the bottom of the reservoir could exhibit some leaks at the interface between the reservoir and the fitting.If a leak occurs due to a crack in the bottom of the reservoir, foaming may occur in the glass jar in the bulk fluid drawer and cause the instrument to stop with vacuum low error # 01 600 13 24.
  • Action
    Siemens are advising users to avoid any potential leak onto the floor by performing the following action during the weekly maintenance: - Verify that no fluid has accumulated under the Waste reservoir. - Verify that the glass jar in the bulk fluid drawer is empty and is not foaming. Siemens will replace the defective reservoir.

Device

ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)
  • Model / Serial
    ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)Siemens Material Number: 10711433ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA