Events

Alerte De Sécurité sur ADVIA CENTRALINK Technical Name: Software ANVISA Registration Number: 10345161928 Hazard Class: I Affected Model: ADVIA CentraLink Affected serial numbers: DC1733486, DC1740245, DC1689706, 5699N3J, JYKZN3J, 66MDN3J, GBY382J, DC1751283, DC1793356, DC18449841, DC1846667, DC1892717, DC1906259, DC1921198, DC1921200, DC1916941, DC1948495, DC1950630, DC1703782

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2078
  • Date
    2016-12-16
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Siemens recommends that the LIS specify the type of sample in the work order. CentraLink software is designed to operate in an environment in which information pertaining to the type of sample is specified in the order that is received from the LIS. The CentraLink configuration will be reviewed. If the LIS does not include information regarding the type of sample in the sample order sent to CentraLink and pre-tests checked against the sample type, the settings will be updated. Siemens does not recommend retroactive analysis of previously generated results.
  • Cause
    Siemens healthcare diagnostics has determined that there is a remote possibility for centralink to send an order to the advia automation system without specifying the type of sample. this event may occur when an order is received from the lis without the sample type information, requiring that such sample type information be placed in centralink based on the type of test sample in the order.
  • Action
    Field Action Code ISW 17-01 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Notification to the client.

Device

ADVIA CENTRALINK Technical Name: Software ANVISA Registration Number: 10345161928 Hazard Class: I...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA