Events

Alerte De Sécurité sur APPLICATOR SET IN TANDEM AND RING FOR BRAQUITERAPIA / GAMMAMED EQUIPMENT FOR TREATMENT BY BRAQUITERAPIA. ALL SERIAL NUMBERS. REGISTRATION N ° 10405410009.

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 Varian Medical Systems Inc. - USA. Varian Medical Systems do Brasil Ltda - Rua Carlos do Pinhal, 696 9° Andar Conj 91-92-93 Bela Vista São Paulo SP CEP:01333-000..

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
    929
  • Date
    2008-06-19
  • 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
    According to information from Varian Medical Systems of Brazil Ltda., Only one affected equipment was commercialized in Brazil. The company informed the Anvisa Technovigilance Unit that it has already contacted the hospital user of the product and provided information to assist in correcting the problem. Anvisa's Technovigilance Unit is monitoring this case.
  • Cause
    Inaccuracies in positions within the ring may result in unintended delivery of doses to the patient.
  • Action
    The user must identify and isolate the equipment under risk and notify the company that owns the product registration in Brazil (Varian Medical Systems Ltda. - Tel: (11) 3457-2655). The product manufacturer recommends that users characterize all ring applicators in order to correct the offset to each equipment stop position - so that the user can build better accuracy and reliability planning. The characterization can be done by creating a set of X-rays with the marking of the stop positions and the definition of the displacement of the planning for the treatment of the appropriate stop positions. After this procedure, the user must perform a new set of x-ray checks using the new offsets, in order to verify the correction of the stop positions.

Device

APPLICATOR SET IN TANDEM AND RING FOR BRAQUITERAPIA / GAMMAMED EQUIPMENT FOR TREATMENT BY BRAQUIT...

Manufacturer

Varian Medical Systems Inc. - USA. Varian Medical Systems do Brasil Ltda - Rua Carlos do Pinhal, ...