Events

Alerta De Seguridad para Positron Emission Tomography Equipment Technical Name: Positron Emission Tomography Equipment ANVISA Registration Number: 10345162013 Hazard Class: III Model Affected: Biograph mCT / Biohgraph mCT Flow Affected Series Numbers: 1010; 11045; 11046 ; 11072 and 11036

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solution S.A..

¿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
    2075
  • Fecha
    2017-01-11
  • 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
    If there is no light marker window or if it is loose, you should not use Biograph mCT or Biograph mC Flow, and the user should immediately contact the local Siemens Service Engineer to solve the problem . Ensure that this note for the customer is included in the Biograph Operator's Manual and is disclosed to all operators of the Biograph mCT and Biograph mCT Flow systems.
  • Causa
    Siemens healthcare diagnósticos sa informs that according to vendor information there may be hardware problems involving the light marker window. the light marker windows used for the positioning laser and integrated in the front of the biograph mct or biograph mct flow systems can loosen and potentially fall.
  • Acción
    Field Action Code MI516 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

Positron Emission Tomography Equipment Technical Name: Positron Emission Tomography Equipment ANV...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solution S.A.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA