Events

Retiro De Equipo (Recall) de EKOS EkoSonic Control Unit

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
    66504
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0133-2014
  • Fecha de inicio del evento
    2013-10-02
  • Fecha de publicación del evento
    2013-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122511
  • 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 ekosonic control unit is recalled because it had the incorrect power entry module installed. it is missing an ac filter to reduce the noise and electrical interference.
  • Acción
    EKOS notified their customer by email on October 2, 2013, about the recall. EKOS has requested the customer to return of EkoSonic Control Unit PT3B-783, so that it can be replaced. CORRECTIVE ACTION: This single affected unit will be reworked with the correct power entry module and released into finished goods as a refurbished control unit. EKOS did not distributed any affected devices in the US. For any questions, please call EKOS Corporation at 425-415-3100.

Device

EKOS EkoSonic Control Unit
  • Modelo / Serial
    PT3B-783.   PT3B represents the model number. Adding 783 creates the serial number.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution in Germany only.
  • Descripción del producto
    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. || The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile 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