Events

Alerta De Seguridad para X-ray System - 9800 Plus, GE Healthcare, registration 80071260009, model 9800 PLUS, hazard class III, all equipment

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.

¿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
    1758
  • Fecha
    2015-11-24
  • 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 letter refers to all of the serial equipment described in the alert.
  • Causa
    According to the registry holder information, the images are not saved in the image directory associated with the 9800 plus system.
  • Acción
    The company will send a Letter of Warning and will provide an add-on to the Operator's Manual. Performing other functions (swap, recall, reverse, etc.) while the system is saving an image may result in a failure to save the image in the images directory. When an image is retrieved from the images directory, it may not match the thumbnail. Note that systems with software version 29 and earlier do not show the Save icon, but the sound will work. Press the Help icon to display the software version screen. To access the supplemental text, go to: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library and enter the number 5440340-199-01. More information access Urgent Notice Letter.Code of Action: FMI15129

Device

X-ray System - 9800 Plus, GE Healthcare, registration 80071260009, model 9800 PLUS, hazard class ...

Manufacturer

GE Healthcare do Brasil