Events

Rappel de Device Recall Penlon Sigma Delta Vaporizer

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 Penlon, Ltd..

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
    65286
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1653-2013
  • Date de mise en oeuvre de l'événement
    2013-05-14
  • Date de publication de l'événement
    2013-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118458
  • 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
    Vaporizer, anesthesia, non-heated - Product Code CAD
  • Cause
    It has come to penlon ltd's attention of an instance where the installation and pre-use checks listed in the user manual may not have been followed prior to the clinical use of the vaporizer. penlon ltd has updated the installation and daily pre-use check sections of the user manual to ensure that the instructions are explicit and clear.
  • Action
    Penlon sent an Urgent Field Safety Notice dated May 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded and requested to follow the instructions for daily pre-use checks, initial checks, and servicing. Customers were instructed to distribute the notice to all personnel who need to be aware within their organization and to any organization where the devices are used. For questions regarding this recall call 01235 547000.

Device

Device Recall Penlon Sigma Delta Vaporizer
  • Modèle / numéro de série
    All; recalled products are traced by serial numbers D0312-XXXX to D1112-XXXX.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including FL, KY, PA, ND, MN, IL, NJ, TX, TN, and VA. Internationally to Belgium, China, Czech Republic, France, Germany, Switzerland, Australia, Finland, Holland, Lithunia, Malta, Poland, and Slovakia.
  • Description du dispositif
    Delta Vaporizer || An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
  • Manufacturer
    Penlon, Ltd.

Manufacturer

Penlon, Ltd.
  • Adresse du fabricant
    Penlon, Ltd., Abingdon Science Park, Barton Lane, Abingdon United Kingdom
  • Société-mère du fabricant (2017)
    BPL Medical Technologies Pvt Ltd.
  • Source
    USFDA