Events

Alerta De Seguridad para OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80071260314. Serial number: see attached chart.

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 HUALUN MEDICAL SYSTEMS CO., LTD..

¿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
    1759
  • Fecha
    2015-11-23
  • 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
    The problem may occur before or during an interventional fluoroscopy procedure. The total and unrecoverable loss of the monitor's display is a risky situation that prevents the use of the equipment for any need and therefore will require another equipment or that the patient is transferred. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and replacement parts.
  • Causa
    Security issue related to video loss of monitors during interventional procedures. a video switch power failure can result in loss of real-time video and reference monitors located in the procedural and control room areas. no radiology images will be displayed during a real-time acquisition or during review when the power supply fails.
  • Acción
    According to company information, the user can continue to use the system. Prior to each use, established procedures should be in place to treat patient in case of loss of fluoroscopy imaging during an examination. The user must ensure that the equipment operates before use. If the failure occurs during the interventional examination, it is advised to interrupt the acquisition of the image immediately and finish the examination to avoid unnecessary exposure. The company will contact you to replace the power supply of the video switch. Action code: FMI12237.

Device

OPTIMA CARDIOVASCULAR IMAGIOLOGY SYSTEM, models CL323 and IGS320, risk class III, registration 80...

Manufacturer

GE Healthcare do Brasil; GE HUALUN MEDICAL SYSTEMS CO., LTD.