Events

Rappel de Device Recall VisualICE Cryoablation 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 Galil Medical, Inc..

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
    62871
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2261-2012
  • Date de mise en oeuvre de l'événement
    2012-07-20
  • Date de publication de l'événement
    2012-08-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111916
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Cause
    Galil medical is recalling a number of visual ice cryoablation systems because the gas regulators may fail to regulate the gas pressure, rendering the devices inoperable.
  • Action
    Galil Medical sent a "Voluntary Medical Device Field Correction" letter dated July 20, 2012, via UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Galil Field Service team will be contacting customers to schedule a service visit the week of July 23rd. Customers were instructed to forward and communicate this field correction notice and instructions to individuals in their organization and/or to other organizations affected by this action. For questions call Galil Medical Customer Service.

Device

Device Recall VisualICE Cryoablation System
  • Modèle / numéro de série
    VL0004 VL0014 VL0015 VL0016
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
  • Description du dispositif
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 || Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
  • Manufacturer
    Galil Medical, Inc.

Manufacturer

Galil Medical, Inc.
  • Adresse du fabricant
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • Société-mère du fabricant (2017)
    Btg Plc
  • Source
    USFDA