Events

Alerta De Seguridad para X-ray System for Mevatron Therapy M, Registry 10234230021 - Serial Numbers: 3054; 3221; 3229; 3589; 3588; 3581; 3585; 3559; 3554; 5065; 5103; 5197; 5288; 5302; 5312; 5344; 5389; 5422; 5484; 5524; 5542; 5637; 5669; 5677; 5697; 5770; 5788; 5885; 2752; 3655; 3787; 3857; 3889; 3913; 3906; 3911; 3927; 3903; 70-4118; 70-4203; 2346; 2946; 2747; 2809; 2651; 2879; 2591.

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 Systems.

¿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
    1496
  • Fecha
    2015-01-19
  • 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
    The registry holder informs that if there is plaque overheating, there is potential for a fire or even smoke emission from the system to be inhaled and consequently medical treatment may be required, depending on the patient's distance and the amount of smoke emitted.
  • Causa
    Siemens has identified a possible occurrence of sporadic failure of overheating signals on the g41 motherboard, located within the gantry of the linear accelerator. one of the components belonging to the printed circuit board (pcb of the head driver) was determined as the root cause.
  • Acción
    Siemens has redesigned the Hard Driver PCB card to further mitigate the risk of local superheat of the G41 motherboard and is guiding customers to wait for the patch to be replaced in the field to replace the card for which it has been redesigned, to file the letter to the client, and follow the guidelines contained in the letter.

Device

X-ray System for Mevatron Therapy M, Registry 10234230021 - Serial Numbers: 3054; 3221; 3229; 358...

Manufacturer

Siemens Ltda.; Siemens Medical Systems
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA