Events

Rappel de Cynosure

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 Cynosure, 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
    69463
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0169-2015
  • Date de mise en oeuvre de l'événement
    2014-10-09
  • Date de publication de l'événement
    2014-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130718
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Cause
    If the laser system is turned on and the user adjusts, installs or removes the xpl pulsed light handpiece, there is a potential risk of an electrical shock.
  • Action
    Cynosure sent an Urgent Medical Device Recall Notification dated October 9, 2014, to all affected customers. They were also notified by phone. The letter identified the product the problem and the action needed to be taken by the customer. There are two methods for returning the Elite XPL handpieces. If the handpiece is NOT currently connected to the laser console, the customer will be asked to return it to the Cynosure office. If the handpiece is not connected there is no risk. If the handpiece is currently connected to the laser console, the customer is instructed to immediately discontinue use of the laser system and to turn off the system immediately. They are also being instructed to leave the handpiece attached to the console and to not touch it. A Cynosure Field service engineer will then come to the office and remove the handpiece and return it to the Cynosure factory. In addition, the Cynosure Field Service engineer will install an interlock into the connector receptacle on the laser console. This interlock plug is an existing component that is used on systems that do not have an IPL handpiece in place. If your XPL pulsed light handpiece is not attached to the laser system please call Cynosure customer service (1-877-222-6822) to arrange for the handpiece to be returned and repaired.

Device

Cynosure
  • Modèle / numéro de série
    All Serial numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
  • Description du dispositif
    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
  • Manufacturer
    Cynosure, Inc.

Manufacturer

Cynosure, Inc.
  • Adresse du fabricant
    Cynosure, Inc., 5 Carlisle Rd, Westford MA 01886
  • Société-mère du fabricant (2017)
    Hologic Inc
  • Source
    USFDA