Events

Alerta De Seguridad para APPLICATOR SET IN TANDEM AND RING FOR BRAQUITERAPIA / GAMMAMED EQUIPMENT FOR TREATMENT BY BRAQUITERAPIA. ALL SERIAL NUMBERS. REGISTRATION N ° 10405410009.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por 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..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    929
  • Fecha
    2008-06-19
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    Inaccuracies in positions within the ring may result in unintended delivery of doses to the patient.
  • Acción
    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, ...