Alerta De Seguridad para Trade name: MOSAIQ. Technical Name: Software de Planej. of Trat. by Radiacao. ANVISA registration number: 80569320004. Class of risk: III. Affected template: All versions. Affected serial numbers: Linear Accelerators with RATM license

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; IMPAC Medical Systems, Inc..

¿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
    Read and follow the Important Field Security Notice (371-01-MSQ-011). Once received, perform the actions described in the IFSN and sign the receipt, sending it to your Elekta representative as soon as possible, but within a maximum of 30 days. 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: 05/24/2017 - Date of notification notice to Anvisa: 07/08/2017 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
    We received the information about the table offset in the vertical direction, which was reversed. an investigation confirmed that the inversion occurred during cma (couch move assistant) use and only on the vertical axis. an inverse change will result in the patient being out of position for twice the magnitude of the change. for example, if a displacement of 1 mm in the wrong direction has occurred, the patient will be 2 mm from the desired position. the machine characterization (mac) file is critical to the correct operation of mosaiq and elekta linac. elekta became aware of this issue on june 24, 2017 of a customer complaint (02364349), reported in the field in germany. a total of 26 patients with more than 50 events where treated outside the intended position.
  • Acción
    Field Action Code FCA-IMS-0024 triggered under the responsibility of the company - Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Correction of parts / parts.