Events

Retiro De Equipo (Recall) de Device Recall pcFM Software Kit

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 Volcano 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
    60867
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0973-2012
  • Fecha de inicio del evento
    2010-06-11
  • Fecha de publicación del evento
    2012-02-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106686
  • 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
    ComboMap System pcFM - Product Code IYO
  • Causa
    Internal review of validation of pcmf software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
  • Acción
    The firm, Volcano Corporation, sent an "IMPORTANT PRODUCT INFORMATION" letter dated June 17, 2010 to all customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the pcFM Software kit to: Volcano Corporation at 2870 Kilgore Road, Rancho Cordova, CA 95670 and contact (800) 228-4728 for instructions on returning the product. The customers were also instructed to complete and return the attached Customer Reply Letter form to Volcano even if they no longer use the pcFM Software Kit via fax to Volcano Customer Support at (916) 638-8812. If you have any questions, contact your Sales Representative or Customer Service at (800) 228-4728.

Device

Device Recall pcFM Software Kit
  • Modelo / Serial
    Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.
  • Descripción del producto
    Volcano pcFM Software Kit ; || Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. || The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Dirección del fabricante
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA