Events

Rappel de Device Recall Ellipse Nordlys 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 Ellipse A/S.

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
    74189
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1698-2016
  • Date de mise en oeuvre de l'événement
    2016-05-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146673
  • 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
    Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
  • Action
    Ellipse A/S has evaluated our instructions in the Service Manual and brought those parts into the Operator's Manual as well which we believe is relevant and usable for the end-user of the product. The details in efficiently implementing the distribution of the manual has been evaluated and coordinated with our service provider in the US. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. For further questions, please call (760) 798-9550.

Device

Device Recall Ellipse Nordlys system
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
  • Description du dispositif
    Ellipse ND: YAG Laser applicator for Ellipse Nordlys system || Medical Laser Products.
  • Manufacturer
    Ellipse A/S

Manufacturer

Ellipse A/S
  • Adresse du fabricant
    Ellipse A/S, Agern Alle 11, Horsholm Denmark
  • Société-mère du fabricant (2017)
    Lupert Ltd
  • Source
    USFDA