Events

Alerta De Seguridad para Equipment Affected: X-ray system for Meratron M Therapy, registration 10234230021, risk class III, series affected: 3229; 3554; 3559; 3581; 3585; 3588; 3589; 3655; 3787; 3857; 3889; 3903; 3906; 3911; 3913; 3927; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 70-4118; 70-4203. /// Linear Accelerator PRIMUS HI, registration 10234230073, Class of risk III, series affected: 3598; 3752; 5509; 5526. /// Oncor linear accelerator, registry 10234230125, risk class III, series affected: 5287; 5386.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; SIEMENS Medical System, 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
    1626
  • Fecha
    2015-05-25
  • 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 manufacturer there is a possibility of collision of the linear accelerator gantry with the patient or the treatment table.
  • Causa
    When the equipment is switched on, it checks if the position of the gantry has changed when the equipment has been switched off. in some cases, it has been identified as changed, even though it has not been changed since the shutdown. in these cases, the console display starts to flash.
  • Acción
    The company that holds the registry will upgrade the control console software to version 9.2.400.

Device

Equipment Affected: X-ray system for Meratron M Therapy, registration 10234230021, risk class III...

Manufacturer

Siemens Ltda.; SIEMENS Medical System, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA