Events

Alerta De Seguridad para COHERENCE ONCOLOGIST software (integral part of LINEAR PRIMUS ACCELERATOR). ANVISA registration: 10234230073.

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
    959
  • 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
    Siemens Ltda reported that it has already begun sending a letter of communication to customers affected by the problem. The updated software version, containing the correction of the problem, is already being elaborated by the company. #### Update on 04/20/2012: According to communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, of 04/19/12), the field action has already been completed - software fix and addendum to the product operation manual.
  • Causa
    The display of an image window acquired with a flat panel optivue (with software version - coherence oncologist - 2.0 or higher) may be offset relative to the reference image.
  • Acción
    Siemens Ltda, the company that owns the product registration in Brazil, informed the UTVIG / ANVISA that it has already begun sending letters of clarification to the customers affected by the problem. If they have not yet received the company's letter of clarification, users who own the equipment should contact the company (see the Manufacturer Description field in this alert). Users who have already received the letter of clarification should attach it in the Coherence Oncologist manual until the software update is run by Siemens.

Device

COHERENCE ONCOLOGIST software (integral part of LINEAR PRIMUS ACCELERATOR). ANVISA registration: ...

Manufacturer

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