Events

Retiro De Equipo (Recall) de Device Recall EKOS EkoSonic Endovascular System

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 EKOS 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
    71635
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2148-2015
  • Fecha de inicio del evento
    2015-06-24
  • Fecha de publicación del evento
    2015-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138434
  • 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
    Catheter, continuous flush - Product Code KRA
  • Causa
    The connector interface cable (cic) was not recognized by the ekosonic pt-3b control unit.
  • Acción
    Ekos sent an "Urgent Voluntary Medical Device and Replacement" letter dated June 24, 2015, to US customers. The letter identified the product the problem and the action needed to be taken by the customer. The replacement CIC and recall letter were sent by FEDERAL EXPRESS directly to the person responsible for maintaining the EkoSonic System. Tracking numbers and delivery notifications will be retained for each shipment. Letters to Risk Management and Purchasing were sent by REGISTER MAIL. The return cards will be retained for each letter. Customers with questions can contact EKOS Customer Service at 1-888-400-3567.

Device

Device Recall EKOS EkoSonic Endovascular System
  • Modelo / Serial
    CIC Serial Numbers:  19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103,  19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112,  19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118,  19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127,  19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135,  19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144,  19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153,  19598-154, 19598-156, 19598-157, 19598-158.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. || The EkoSonic Endovascular System consists of three main components: || -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and || -removable MicroSonic Device (MSD), and || -a reusable EKOS EkoSonic Control System. || During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. || The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. || A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Dirección del fabricante
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Empresa matriz del fabricante (2017)
    Btg Plc
  • Source
    USFDA