Events

Alerta De Seguridad para Magnetic Resonance Imaging Equipment Optima and Discovery; Records and Models: 80071260118 - Optima MR450W; 80071260300 - Optima MR450W and Optima MR450W and GEM; 80071260134 Discovery MR750W 3.0T; 80071260116 - Discovery MR450. Risk class II, containing the table option: MR Surgical Suite II with model numbers: M8074SS, M8053SS and M0074SS.

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, Com. e Serv.; 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
    1712
  • Fecha
    2015-10-07
  • 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, the unexpected loss of function of the patient transfer mechanism may prevent the transfer of the patient from the MRI table to the surgical table. In this way, the occurrence of this failure can generate delays in the care and treatment of patients during surgical or interventional procedures.
  • Causa
    Unexpected loss of the function of the patient transfer mechanism that allows the patient to be transferred from the mri table to the surgical table. a complaint was made regarding the non-release of the transfer board from the table of resonance preventing the movement of the board towards the surgical table.
  • Acción
    Parts / parts correction. The table can still be used. However, they should be aware of any problems related to the release of the table. If any failure is observed, a GE field engineer should be contacted to correct the problem. Action code: IMF 60885.

Device

Magnetic Resonance Imaging Equipment Optima and Discovery; Records and Models: 80071260118 - Opti...

Manufacturer

GE Healthcare do Brasil, Com. e Serv.; GE MEDICAL SYSTEMS LLC.