Events

Alerte De Sécurité sur Hospital Medical Equipment

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 A PAULISTINHA COMÉRCIO E SERVIÇO LTDA.

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
    764
  • Date
    2003-12-18
  • 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 § 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the provisions in art. 1 and 2 of DRC-25, of February 15, 2001; considering the provisions of items I and XXIX, of Article 10, of Law No. 6.437, of August 20, 1977; considering the Inspection Report held in the company on August 27, 2003, reporting the lack of licensing and the sale of refurbished hospital medical equipment in disregard of the current norm; considering the AIF Infringement Notice No. 101 dated August 27, 2003, drawn up by VISA-DIR-I / SES-SP, resolves: Article 1 To determine, as a precautionary measure, as a measure of health interest, in all territory national, the suspension of the sale and distribution of health products (correlates)
  • Cause
    Lack of licensing and the commercialization of refurbished hospital medical equipment in disagreement with the current norm;.
  • Action
    Suspension of the sale and distribution of health products (correlates)

Device

Hospital Medical Equipment

Manufacturer

A PAULISTINHA COMÉRCIO E SERVIÇO LTDA
  • Source
    ANVSANVISA