Events

Alerta De Seguridad para Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073 Hazard class: III Serial numbers affected: 5529; 5746; 5828

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 AG; Siemens Medical Solutions USA, 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
    2225
  • Fecha
    2017-03-14
  • 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
    Despite security measures, there may be scenarios that are not covered by the software. Therefore, during automatic sequencing, the operator must pay attention to any movements of the gantry and the treatment table, and deviations or overlaps of the table applied in accordance with the treatment plan and carry out the preventive measures described in the letter of notification TH012 / 14 / S.
  • Causa
    Siemens healthcare diagnostics reports that previous afs motion protection software considered only the critical definitions of isocentric and eccentric table positions, but not a lateral deviation from the treatment table. in addition, the previous software required that the table setting be set to "automatic" in all parameters. if the operator had set the table's isocentric rotation to "manually" and the order of movements to "table first", the previous software ignored this setting. if a move from the gantry and the table to the next treatment field was required, the software did not stop the afs so as to allow manual table movement before the gantry moves, which would be automatically moved to the next target position.
  • Acción
    Field Action Code TH005 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration numb...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA