Events

Recall of ADVIA CENTAUR XPT INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    43406
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has identified issues with the advia? centaur xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) and v1.0.3 (bundle 1.0.1108 smn 11220781) that may affect the operation and workflow of the system. issues 1-12 will be corrected in software version 1.1 (bundle 1.1.243 smn: 11221979) which will soon be available for installation on all systems. the actions to be taken section indicates if the specific issue is corrected in v1.1. for issues corrected in software version 1.1 the actions do not need to be performed after the system has been upgraded to software version 1.1. issues 13-20 will be corrected in future software versions.

Device

ADVIA CENTAUR XPT INSTRUMENT
  • Model / Serial
    Model Catalog: 10711433 (Lot serial: 62866); Model Catalog: 10711433 (Lot serial: 10057); Model Catalog: 10711433 (Lot serial: 9223)
  • Product Description
    ADVIA CENTAUR XPT INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC