Events

Retiro De Equipo (Recall) de Device Recall Philips Volcano Core M2Imaging Systems

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
    79715
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1891-2018
  • Fecha de inicio del evento
    2018-03-22
  • 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=163160
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Causa
    The incorrect resistor has been used in affected core m2 imaging systems, which causes noise and results in an overly bright ivus image.
  • Acción
    Customers were notified on 03/21/2018. U.S. customers were notified via hand-delivered Urgent Medical Device Recall letters; foreign customer letters were mailed. The letter identified the affected device and the reason for the recall. Instructions included to stop usage of the device and to call remote support at 1-800-228-4728, to schedule a visit to replace the affected device. Customers were instructed to complete and return the customer response form or to provide the form to Philips representatives. Customers were also instructed to provide copies of the recall notification to all personnel within their organization who handled this device.

Device

Device Recall Philips Volcano Core M2Imaging Systems
  • Modelo / Serial
    Serial #: 126620101597, 126620101599, 126620101600, 126620100718, 126620102313, 126620102315, 126620102307, and 126620093077.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.
  • Descripción del producto
    Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. || Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
  • 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