Events

Alerte De Sécurité sur Registration number: ADVIA Centaur Systems //// Registration ANVISA: 10345161944. Risk class I //// model: ADVIA Centaur XPT /// Serial Numbers: IRL07221522; IRL08401537; IRL09721551; IRL09741551; IRL09801552; IRL10151604

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
    1927
  • Date
    2016-06-24
  • 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
    If you have any questions regarding this field action, please contact: E-mail temas.regulatorios.br@siemens.com Internet www.siemens.com Telephone 0800 129 633 Fax (11) 3908-3995
  • Cause
    The manufacturer has identified problems related to: sample tip error, daily maintenance, release of sample results below / above linearity, auto-repeat conditions processing of results it is possible that a sample tip error or a failure to complete the daily cleaning procedure, which could lead to discrepant results for patient samples and quality controls. according to the registrant of this product, the likelihood of these faults occurring is extremely unlikely (siemens points out that failure to complete the daily cleaning procedure may occur if fluid systems are not filled in prior to commencing the daily procedure). for the other problems described in the portuguese charter there is a potential for delay in releasing the result.
  • Action
    Action code CSW 16-04. Letter Sending, prepared in May / 2016, to Customers.

Device

Registration number: ADVIA Centaur Systems //// Registration ANVISA: 10345161944. Risk class I //...

Manufacturer

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