Events

Alerta De Seguridad para Magnetic Resonance Imaging Equipment, risk class II: MR SIGNA EXCITE, models 1.5T and 3T, registration 80071260061 /// Signa Excite, model Signa HD 1.5T and Signa HD3.0T, registration 80071260088 /// Signa Excite, model HDx1. 5T and HDx3.0T, registration 80071260081 /// Magnetic Resonance, Signa HDxt 1.5T and Signa HDxt 3.0T, registration 80071260103 /// Signa Hdi, register 80071260102.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil; GE Medical Systems LLC.

¿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
    1641
  • Fecha
    2015-07-20
  • 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 record holder the flaw can cause left-right inversion in the images with incorrect guidance annotations. #### Update of the field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    No spacer on the x-axis gradient cable used in acgd mr cabinet to prevent connection with incorrect polarity.
  • Acción
    The company will fix the problem in the field and instruct customers to continue to use the device in accordance with current maintenance procedures. It is important that the Service Engineer perform the geometry check after the maintenance of your system. This scan will detect the problem.

Device

Magnetic Resonance Imaging Equipment, risk class II: MR SIGNA EXCITE, models 1.5T and 3T, registr...

Manufacturer

GE Healthcare do Brasil; GE Medical Systems LLC