Events

Alerte De Sécurité sur Generators of Radio-Frequency Model 4810. UPN. M00448100

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 Boston Scientific/EP Technologies.

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
    552
  • Date
    2000-03-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    An ecri member hospital reported that there was a failure of communication between the micro-electronic program components in the above radio-frequency generators. this communication failure puts the device in fail-safe mode, rendering it inoperative. the manufacturer states that this problem began on january 2, 2002. the manufacturer initiated a correction for a notification during the week of january 7, 2002 by federal express.
  • Action
    Verify that you received the January 2002 Boston Scientific Correction Notice. Identify and isolate any affected product in your inventory. If your unit (s) has not received coverage from this service, please contact your EP Technologies sales representative, who will put you in touch with the appropriate person at Boston Scientific. For more information, contact Boston Scientific / EP Technologies in the USA by phone at (1408) 895-3626, or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Generators of Radio-Frequency Model 4810. UPN. M00448100

Manufacturer

Boston Scientific/EP Technologies
  • Source
    ANVSANVISA