Events

Retiro De Equipo (Recall) de 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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00926-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00926-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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 (...
  • Modelo / 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
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA