Events

Alerta De Seguridad para X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Registry nº10216710209, COMPUTERIZED TOMOGRAPHY EQUIPMENT Mx8000 DUAL vEXP PHILIPS BRAND, ANVISA Registry nº10216710142.

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..

¿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
    1232
  • Fecha
    2013-02-06
  • 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
    If the table is moved down unexpectedly, please discontinue use of the equipment and contact the Service Support of your local Philips equipment. If you need additional information or support regarding this issue, please contact the Solution Center at 0800-701-7789. Customer Service to sab from 7:00 a.m. to 7:00 p.m.
  • Causa
    Philips healthcare received field reports stating that the patient's desk in one system presented an unexpected descent movement while the patient was on it. philips has determined that the bed brake has malfunctioned due to deterioration of the vertical brake bolts. the following ct systems affected: • ct brilliance series: 6,10,16,16 power, 40, 64, big bore, big bore oncology, ict, ict sp, ingenuity core, ingenuity ct, mx8000 dual v. exp. there is a possibility that the vertical brake may fail while the patient is on the table and the table is raised. although no serious injury has been reported, if the vertical brake malfunctions, the technician, patient, or other persons near the table may be injured. system serial numbers brilliance ct 6 affected, access: http://portal.Anvisa.Gov.Br/wps/wcm/connect/109a64004e998c8aae88ae8a610f4177/aviso_de_seguranca_fco72800577.Pdf?mod=ajperes.
  • Acción
    The Philips Equipment Service Engineer will perform the brake repair or replace the system to solve the problem.

Device

X-RAY SYSTEMS FOR COMPUTERIZED TOMOGRAPHY, ANVISA Registry nº10216710191, INGENUITY CT, ANVISA Re...

Manufacturer

PHILIPS MEDICAL SYSTEMS LTDA.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA