Events

Alerta De Seguridad para ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.

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..

¿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
    958
  • Fecha
    2009-03-12
  • 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 a communication letter sent to UTVIG / ANVISA by Siemens Ltda, the company will send a communication letter to its customers. The company also reported that equipment under risk in the country has not yet been installed, that is, they are not yet in operation. #### Update on 04/20/2012: According to communication sent on 04/17/2012, 2012 by the company for UTVIG / ANVISA (file no. 0324770128 of 04/19/12), the company has already closed the field action. The three equipments affected by the problem in Brazil were corrected by the company through a software update.
  • Causa
    The display of the equipment may be misaligned by about 4mm when compared to the reference image. with this, a single exposure image can be overwritten by a dual exposure image.
  • Acción
    The company that owns the product registration, Siemens Ltda, has not yet begun to communicate with users affected by this alert. According to the company, to avoid the possibility of overwritten images from a single exposure by a dual exposure image, users should acquire / load images of the same type of exposure during a session. If this recommendation is difficult to implement at the health facility, users are advised to select SAVE (save) to each image immediately after a modification. The ANVISA Technovigilance Unit (UTVIG / ANVISA) is monitoring this case.

Device

ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.

Manufacturer

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