Events

Retiro De Equipo (Recall) de 867098 Philips Network Firewall (Cisco ASA 5506 Firewall)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Electronics North America Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78849
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0850-2018
  • Fecha de inicio del evento
    2017-10-05
  • Fecha de publicación del evento
    2018-03-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160720
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    Firewall installed with philips intellivue information center ix or information center classic may have a defective component, which may result in loss of connection to the information center ix. the defect involves the clock signal component within the firewall. this component has a high probability of failing in appliances that have been running for greater than 18 months. if the clock signal component were to fail, the firewall will stop functioning, will not boot, and is not recoverable. this failure will result in loss of communication between devices that are separated by the firewall, which may cause the information center to reboot.
  • Acción
    Philips sent an Urgent Recall Notice letter dated October 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a Philips representatives will contact affected customers to arrange for replacement of all affected units supplied by Philips. For questions contact your local Philips representative: Philips Customer Care Solution Center 800-722-9377.

Device

867098 Philips Network Firewall (Cisco ASA 5506 Firewall)
  • Modelo / Serial
    Serial Numbers for use in U.S.A.: JMX2030Y2B8 JMX2030Y2CR JMX2030Y2BN JMX2030Y2AY JMX2040Y2NZ JMX2022Y1U4 JMX2040Y2NU JMX2045Y2L0 JMX2030Y2D9 JMX2030Y2B1 JMX2035Y0XC JMX2035Y0XT JMX2030Y2DY JMX2035Y0XA JMX2040Y2R2 JMX2031Y0EV JMX2039Y1FZ JMX2030Y2BT JMX2030Y2EE JMX2030Y2DM JMX194840WA JMX2014419Y JMX201441AB JMX201441A4 JMX2014Z155 JMX2014Z15C JMX2014Z15L JMX2039Y1H7 JMX2039Y1H5 JMX2039Y1HR JMX2039Y1JM JMX2022Y194 JMX2018Z009 JMX2022Y15F JMX2040Y2QP JMX2030Y2PZ JMX2045Y2E4 JMX20184033 JMX2030Y2A8 JMX2039Y1GB JMX2040Y2P9 JMX2030Y2E6 JMX2030Y2EG JMX2022Y181 JMX2022Y1A7 JMX2040Y2QW JMX2030Y2B6
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide
  • Descripción del producto
    Philips Network Firewall (Cisco ASA 5506), Model # 867098
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Dirección del fabricante
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA