Events

Alerta De Seguridad para Equipment For Angiography, Image Guided System, Model INNOVA IGS 530, Hazard Class III, Record: 80071260269, serial number of the affected unit: XV650620BU8.

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 SYSTEM S.C.S..

¿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
    1604
  • Fecha
    2015-06-07
  • 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 company, if the Gantry Motion Control Board (MCB) fails, limiting the movement of the fluoroscope may interfere, complicate or prolong any interventional procedure that is dependent on multiple fields of view , affecting the diagnostic and therapeutic accuracy of the image. The ability to perform imaging and diagnostics can also be impaired.
  • Causa
    Safety problem related to the loss of the ability to move the arm gantry in c (c-arm) in the system of interventional imaging of fluoroscopy. loss of gantry movement capacity is caused by a failure in the gantry motion control board (mcb). after system reboot, x-rays and manual movements of the gantry and table shafts will be available.
  • Acción
    The company will make a field correction of the affected equipment. The user can continue to use the system, avoiding abrupt changes of direction with the movements of the gantry and preventing potential collisions with other equipment. If failure occurs during an interventional examination / procedure, the user should ensure that he / she has the procedures in place to handle patients in the event of loss of gantry movement as described on the labeling of their product.

Device

Equipment For Angiography, Image Guided System, Model INNOVA IGS 530, Hazard Class III, Record: 8...

Manufacturer

GE Healthcare do Brasil; GE MEDICAL SYSTEM S.C.S.