Events

Alerte De Sécurité sur Angiography Equipment ALLURA XPER. Register Anvisa n ° 10216710153. Products under risk in Brazil: models with codes 722003,722005, 722006, 722008, 722014, 722015, 722019, 722020 with software version 7.2.X.

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 Nederlands 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
    1522
  • Date
    2015-03-06
  • 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
    This is an electronic defect in the intermittent alarm of the product, which in certain circumstances may lead to a situation in which the five-minute sound signal from the fluoroscopy does not sound. Through customer complaints and internal testing, Philips Healthcare has discovered an intermittent electronic defect in the product. According to the company, the problem does not create a dangerous situation, however the beep is an available tool to help avoid the excessive incidence of radiation in the patient. See Security Notice published by the company, available at: http://portal.anvisa.gov.br/wps/wcm/connect/f4260380478c61258259ebfe096a5d32/Aviso+de+Seguran%C3%A7a+-+FCO72200270.pdf?MOD=AJPERES
  • Cause
    Five minute product alarm does not sound intermittently.
  • Action
    Philips will perform a software update to fix the alarm problem (installation of the new version R7.2.8). Until software correction is performed, the user must observe the real-time dosing information and accumulated fluoroscopy time reported by the system - the failure condition is restored when a new patient case is initiated, or when the system is restarted.

Device

Angiography Equipment ALLURA XPER. Register Anvisa n ° 10216710153. Products under risk in Brazil...

Manufacturer

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