Events

Alerte De Sécurité sur Brachytherapy System, Transfer Device, Beta-Cath

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 Novoste Corp.

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
    547
  • Date
    2002-03-01
  • 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
    The fda reported that novoste initiated a correction of the above apparatus after the company had determined that the rails of the source of radioactivity in the above apparatus were incorrectly calibrated by the manufacturer and that they were shipped with incorrect prescription label information. it was estimated that the calibration processes of the devices have an error of 11%. the manufacturer states that the affected appliances pose no great health risk than is already present in any vascular brachytherapy procedure. the manufacturer initiated a correction per letter.
  • Action
    Make sure you received the letter from Novoste. Identify and isolate any affected product in your inventory. Return the affected product to Novoste at the address below; improperly calibrated apparatus will be replaced with appropriately calibrated apparatus. For more information, contact Novoste USA at (1770) 717-0904, or contact 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 more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Brachytherapy System, Transfer Device, Beta-Cath

Manufacturer

Novoste Corp
  • Source
    ANVSANVISA