Events

Rappel de Device Recall EKOS Lysus Infusion System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ekos Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    33408
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0175-06
  • Date de mise en oeuvre de l'événement
    2005-01-18
  • Date de publication de l'événement
    2005-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41817
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Catheter, Continuous Flush - Product Code KRA
  • Cause
    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.
  • Action
    On 1/19/05 the firm began visiting consignees and upgrading software.

Device

Device Recall EKOS Lysus Infusion System
  • Modèle / numéro de série
    Serial numbers PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Ekos Corp, 22030 - 20th Ave SE, Ste 101, Bothell WA 98021
  • Source
    USFDA