Events

Rappel de Device Recall Urethral Warmer 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.

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
    57254
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0832-2011
  • Date de mise en oeuvre de l'événement
    2010-11-11
  • Date de publication de l'événement
    2010-12-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95676
  • 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
    This voluntary recall has been initiated because our supplier (gaymar industries, inc.) notified us that these products contain power cords that may crack or fail at or inside the plug due to a prong design problem. affected plugs can be identified by a round ground pin and black plastic bridges. cords with plugs that are not affected have u-shaped ground pins and no plastic bridges. although gali.
  • Action
    Gaymar sent an URGENT: MEDICAL DEVICE RECALL letter dated September 30, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Customers were instructed to: " Inspect units in their possession to determine if they contain affected power cord plugs or if there were any signs of excessive wear or damage. " Immediately discontinue use and quarantine the affected product. " Contact Customer Service Department at 800-828-7341 to arrange for replacement. " Complete the attached form for each unit and follow the instructions given to return the form by fax or e-mail. " If customers further distributed the product to another person or entity, they were to identify their customers and notify them at once of this product recall by including a copy of the recall notification letter and the attached form. For questions regarding this recall call 800-828-7341 or 716-662-2551.

Device

Device Recall Urethral Warmer System
  • Modèle / numéro de série
    GW469, GW470, GW468, GW472
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
  • Description du dispositif
    Urethral Warmer System Model number FPRCH3001 || The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
  • Manufacturer
    Galil Medical

Manufacturer

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