Events

Alerte De Sécurité sur lung ventilators

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 VENT-LOGOS Sistema Logístico S/A.

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
    759
  • Date
    2003-12-23
  • 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
    considering the provisions of paragraph 3 of Article 111 of the Internal Regulation approved by Administrative Rule no. 593, dated August 25, 2000, republished on December 22, 2000; considering items IV, XXIX, and XXXV of Art.10, of Law no. 6.437, of August 20, 1977; considering Arts. 1, 12, 17 item X and 25, of Law no. 6.360 / 76, of September 23, 1976; considering art. 1 of DRC-59, of 27 June 2000; considering a report of the joint inspection with the Technical Team of the Sanitary Surveillance of the Secretary of State of Health of Espírito Santo on December 5, 2003, reporting the nonconformities recorded in the Company's Quality System VENT-LOGOS SISTEMAS LOGISTICOS S / A, ; considering the Notice of Infringement No. 307935 and the Term of Interdiction No. 307935 issued by the State Department of Health of the State of Espírito Santo, resolves: Article 1 - To determine, as a precautionary measure, throughout the national territory, suspension of sale and banning of all products (pulmonary ventilators)
  • Cause
    Failure to comply with the requirements of good manufacturing practices established in drc 59/00;.
  • Action
    Suspension of sale and banning of all products

Device

lung ventilators

Manufacturer

VENT-LOGOS Sistema Logístico S/A
  • Source
    ANVSANVISA