Events

Alerte De Sécurité sur Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Class of risk: III. Allura Xper FD1O / Allura Xper FD1O / 10 Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD2O / Allura Xper FD1O / Allura Xper FD1O / Allura / Allure Xper FD2O / 1 / Allura Xper FD2O / 1 5 OR Table. List of lots / series: 285/306/308/322/379/565/405/639

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 Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V..

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
    1970
  • Date
    2016-06-23
  • 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 action, please contact Philips by phone: 0800 701 7789
  • Cause
    Philips healthcare has discovered, by means of trend analysis, an increase in the error rate of certain low voltage dc ("facc") power supplies used in these products. each system contains multiple faccs, some of which may be subject to a high probability of error. failure of a facc may result in the sudden loss of image acquisition or mechanical motion functionality, depending on which subsystems the facc is feeding. the severity was classified as resulting in severe injury: life threatening or permanent damage or need medical intervention to avoid permanent damage. the probability of occurrence was classified as possible but unlikely. the conclusion of the risk analysis was not acceptable.
  • Action
    Field action FCO72200371 Sending letter to clients (attached) // FACC replacement affected.

Device

Product Category: Angiography Equipment Allura Xper. Registration number ANVISA: 10216710153. Cla...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA