Events

Rappel de Device Recall NanoKnife

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 Angiodynamics Worldwide Headquarters.

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
    60707
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0918-2012
  • Date de mise en oeuvre de l'événement
    2012-01-20
  • Date de publication de l'événement
    2012-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106275
  • 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
    Low energy direct current thermal ablation system - Product Code OAB
  • Cause
    Angiodynamics was marketing the nanoknife system with the ablation zone estimator feature in the us without fda clearance.
  • Action
    AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics at 518-798-1360. If customers further distributed the affected product, they should inform those accounts of the field correction. Angiodynamics will also disable the AZE feature during a schedule service visit. For questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.

Device

Device Recall NanoKnife
  • Modèle / numéro de série
    Batch codes: 00800709, 00880909, 00870909, 00630609, 00610609, 00470109, 00080508, 00180608, 00050508, 00460109, 00830709, 00240708, 00500209, 00930909, 00430109, 00480209, 00371008, 01210911, 00650709, 00670709, 00690709, 00850909, 00920909, 00820709, 00860909, 00890909, 00940909, 00780709, 00770709, 00760709, 00910909, 00790709, 00361008, 00750709, 00510209, 00450109, 00421208, 00490209, 00530209, 00600609
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 || Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Adresse du fabricant
    Angiodynamics Worldwide Headquarters, 14 Plaza Dr, Latham NY 12110-2166
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA