Events

Alerta De Seguridad para Commercial Name: Juno DRF Diagnostic X-ray Equipment Technical Name: Fluoroscopic X-Ray System ANVISA Registration Number: 10216710270 Hazard Class: III Affected Model: N / A Serial Number Affected: 16111583

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; Villa Sistemi Medicali S.p.A..

¿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
    2242
  • Fecha
    2017-03-21
  • 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
    Do not use the footrest until the screws that hold the foot are checked by a technician.
  • Causa
    The footrest of the equipment was detached from the table top because the safety screws were discarded in the installation. the purpose of these screws is to prevent the footrest from completely separating from the table to prevent the patient from falling.
  • Acción
    Field Action Code FCO70900035 triggered under the responsibility of the company Philips Medical Systems Ltda. Company will do stock verification.

Device

Commercial Name: Juno DRF Diagnostic X-ray Equipment Technical Name: Fluoroscopic X-Ray System AN...

Manufacturer

Philips Medical Systems Ltda; Villa Sistemi Medicali S.p.A.
  • Source
    ANVSANVISA