Events

Retiro De Equipo (Recall) de Device Recall Cisco

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 Cisco Systems Inc.

¿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
    62770
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2263-2012
  • Fecha de inicio del evento
    2012-07-23
  • Fecha de publicación del evento
    2012-08-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111681
  • 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
    Software transmission and patient data storage medical - Product Code NSX
  • Causa
    Software anomaly may result in incorrect values and interpretations. the initial vital signs reading will display accurately on the cisco health presence vitals tab and the oneplace tab. however, subsequent vital signs readings will only update on the cisco healthpresence vitals tab and within the oneplace database, but will not update under the oneplace tab, and thus, will not provide current vit.
  • Acción
    Cisco notified their one customer by phone on July 25, 2012, with a follow up email and instructed the customer to stop using the OnePlace vitals tab and to use the CHP only. On July 27th, 2012, the vendor of the OnePlace application, fixed the bug remotely. On July 31, 2012, Cisco's staff physician contacted the customer to confirm that the customer was aware of the fix. Validation of the correction was completed by Cisco, along with customer on August 9, 2012. Until validation was satisfactorily completed, the integrated system lie dormant at customer's site.

Device

Device Recall Cisco
  • Modelo / Serial
    Serial/Code Number: 2.1.0.87
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the state of TN.
  • Descripción del producto
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA || Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.
  • Manufacturer
    Cisco Systems Inc

Manufacturer

Cisco Systems Inc
  • Dirección del fabricante
    Cisco Systems Inc, 170 W Tasman Dr, San Jose CA 95134
  • Empresa matriz del fabricante (2017)
    Cisco Systems Inc
  • Source
    USFDA