Events

Alerta De Seguridad para Helix - All configurations - Product with more than 20 years of manufacture

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. para Equipamentos Médicos-Hospitalares Ltda..

¿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
    1461
  • Fecha
    2014-04-09
  • 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 company reports that life-threatening potential may occur if there is unintended movement of the radial detector, leading to contact with the patient. ////// Update - 07/10/2014 - The company informs that 9 clients received the letter referring to this field action, giving notice of the interruption of the use of the equipment. It was verified that the system with identification 0252A was deactivated.
  • Causa
    The company ge healthcare of brazil reported that during a whole body scan, the detector can move to the initial position, and then slowly starting the internal movement towards the patient. this movement will generate both a visual and audio alert condition on the console and the gantry. this mode of failure was observed in a single system.
  • Acción
    The company directs users to immediately stop using this system and confirm by letter that the system has been withdrawn from service. Due to the date of manufacture and the life cycle of the Helix product, the user will already have received a letter from GE Healthcare in 2008 stating that the product was at the end of its useful life, that GE would no longer issue service contracts for these systems and that there would be no more spare parts support. You should confirm that you have disabled the system by completing the enclosed Customer Response Form. If the user wants help with the removal and disposal of their Helix system, GE Healthcare will do so at no cost.

Device

Helix - All configurations - Product with more than 20 years of manufacture

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médicos-Hospitalares Ltda.