Alerta De Seguridad para Trade name: Azurion. Technical name: Hemodynamic and Angiography equipment. ANVISA registration number: 10216710345. Risk class: III. Affected model: 3 and 7. Serial numbers affected: 151; 152; 295; 383

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda; Philips Medical Systems Nederland B. V..

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The downscale option must be disabled in the export protocols until Philips corrects this problem. To do this, you can refer to Chapter 13.8 (Configuring Export Protocols) of the system usage instructions that describes how to do this. You can also contact your local Philips representative for assistance in performing this action. All archived images exported using the downscale option would be affected by this problem, so such measurements of the archived images should not be used as a reference. Additional precaution can be taken by performing new measurements during the actual intervention procedure. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/13/2018 - Date of notification notice to Anvisa: 03/21/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    To reduce storage space, azurion r1.1 systems include the downscale option of images when exporting to the external dicom destination (eg pacs). when using the downscale option, measurements performed with the azurion r1.1 system using the qa basic measurement tool will not be correctly exported to the external dicom target. the difference between the original measurement and the exported measurement may vary. the distance value after export has a factor of 1 to 4 lower than the original value. the difference will depend on the acquired image (eg x-ray protocol, field of view) and the file settings used (eg scaled-down settings). if the measurement is performed again at the external dicom destination, the result will also be incorrect unless a new calibration of the image is made.
  • Acción
    Field Action Code FCO72200402 triggered under the responsibility of the company Philips Medical Systems Ltda. Field correction.


  • Empresa matriz del fabricante (2017)
  • Source