Events

Retiro De Equipo (Recall) de Device Recall EKOS Lysus Infusion 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 Corp.

¿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
    33408
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0175-06
  • Fecha de inicio del evento
    2005-01-18
  • Fecha de publicación del evento
    2005-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41817
  • 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
    Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
  • Acción
    On 1/19/05 the firm began visiting consignees and upgrading software.

Device

Device Recall EKOS Lysus Infusion System
  • Modelo / Serial
    Serial numbers PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The device was distributed to 6 hospitals/medical centers; 1 each located in AZ, OH, WA, FL, IL, and. CA. One consignee is located Germany.
  • Descripción del producto
    Lysus¿ Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency (2-2.5 MHz), low power (0.45 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) || The Lysus¿ Infusion System consists of three main components, a single use Lysus¿ Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus¿ Infusion Catheter System.
  • Manufacturer
    Ekos Corp

Manufacturer

Ekos Corp
  • Dirección del fabricante
    Ekos Corp, 22030 - 20th Ave SE, Ste 101, Bothell WA 98021
  • Source
    USFDA