Events

Alerta De Seguridad para IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008.

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

¿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
    1526
  • Fecha
    2015-03-11
  • 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
    According to the company's assessment, the severity of the situation is critical if incorrect and unintended positioning occurs for radiation and this is not detected by the user of the product. The possibility of occurrence is remote, as the potential problem occurs only under specific circumstances associated with workflows and specific patient placement scenarios. See Field Safety Notice for additional information. #### UPDATED ON 08/18/2019, the field actions documented by the company are archived in the area. If necessary, the area can reassess the action at any time.
  • Causa
    Potentially incorrect positioning of the patient in linac, when using treatment plans containing several ct scans.
  • Acción
    If it is not clinically necessary, do not use multiple scans located within a treatment plan (to avoid, first, possibly incorrect designations of the Reference Set and Alignment Set). If you need to use multiple CT scans, for example, for recurring treatment planning for the same patient, ensure that the last CT scan is defined as both Alignment Set and Reference Set during treatment planning. See Field Security Notice for more information, available at AWARDING PUBLICATION.

Device

IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008.

Manufacturer

Brainlab Ltda.; Brainlab AG
  • Empresa matriz del fabricante (2017)
    Brainlab AG
  • Source
    ANVSANVISA