Events

Alerta De Seguridad para Allura Xper FD10 Allure Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 ; Allura Xper FD20 / 10; Allura Xper FD20 / 20; Allura Xper FD10 / 10 OR Table; Allura Xper FD20 / 10 OR Table; Allura Xper FD20 / 20 OR Table / Integris Allura 12/15 Integris Allura 9 / 15F Integris Allura 9C Integris Allura 9F. Affected records: 10216710034 /// 10216710153 /// 10216710155 /// 10216710206 .. Serial numbers affected: 176/553/759/1751 / 001H021796 / 001H021878 / S4F200104A / S4F200174A / S4F200270A.

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 Medical Systems (Cleveland), 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
    1542
  • Fecha
    2015-03-20
  • 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
    According to the record holder, there were no reports of injuries due to this failure mode, but when the vertical brake malfunctions, the technician, patient or other users who are near the table may suffer an injury.
  • Causa
    According to the record holder there is a possible fault in the monitor stator actuator assembly. failure to do so may cause the monitor to drop and possible collision with other parts of the equipment, professional or patient.
  • Acción
    The record holder's recommendations are to not position or move the monitor ceiling suspension above the patient; do not allow the staff to remain below or near the ceiling suspension of the monitors and to avoid unnecessary ceiling suspension movements.

Device

Allura Xper FD10 Allure Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper FD10 Allura Xper ...

Manufacturer

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