Events

Alerta De Seguridad para Product trade name: Ultrasound Diagnostic Equipment EPIQ /// Registration number: 10216710275 /// affected model: EPIQ 7 / / / Product hazard class: II.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Ultrasound, Inc..

¿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
    1871
  • Fecha
    2016-04-19
  • 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
    Philips will contact all EPIQ customers to provide replacement service for the connection bolts from the control panel frame to the system by means of bolts less likely to come loose with repeated handling. This service will be provided free of charge. Should you require any additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h.
  • Causa
    The control panel structure of the philips epiq ultrasound system can come loose, with the possibility of this structure detaching from the system. philips has stated that it will contact you to make the necessary repairs to your system.
  • Acción
    Field Classification: Field Correction by replacing the bolts connecting the control panel structure to the system with bolts with less possibility of release with repeated handling /// Action Code Field: FCO79500382 /// Recommendations to Users and Patients: If, at any time, the control panel structure of your ultrasound system oscillates or appears to be loose, immediately stop using your system and contact your representative Local Philips or Philips Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h. Otherwise, you can continue using your system.

Device

Product trade name: Ultrasound Diagnostic Equipment EPIQ /// Registration number: 10216710275 ///...

Manufacturer

Philips Medical Systems Ltda.; Philips Ultrasound, Inc.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA