Events

Recall of CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10811600, 10811601, 10814296, 10814298, 10814877, 10814880, 10814881, 10811741, 10811742, 10811743, 10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10815474 & 10811596ARTG Number: 224615

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

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-2014-RN-00926-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00926-1
  • 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 healthcare diagnostics has identified a task scheduler issue with the centralink data management system, software version 14. the issue may cause the software to stop executing commands, including uploading validated results to the lis. the issue is related to an internal software timer that overflows after 24 days. automated rules triggered by task schedulers or by actions in the centralink user interface may also be affected. the specific consequences of discontinued command execution will vary:1) automated rules will stop running. results may be released to the lis that should have been held based on the automated rules.2) tasks to upload results and download orders to/from the lis will stop running causing a delay in test processing. 3) data in memory may not be updated causing data displayed on reports to not be up to date. however, the lis information would be correct.4) a database backup may not occur when scheduled.
  • Action
    Siemens Healthcare Diagnostics is advising customers to log out of user sessions and restart the CentraLink services and translators as soon as it is convenient. Then periodically (more often than every 24 days) using the procedure provided to restart the CentraLink Data Management System. Siemens is currently investigating further corrective actions. This action has been closed-out on 18/08/2016.

Device

CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (...
  • Model / Serial
    CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10811600, 10811601, 10814296, 10814298, 10814877, 10814880, 10814881, 10811741, 10811742, 10811743, 10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10815474 & 10811596ARTG Number: 224615
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA