Events

Rappel de Device Recall Surgical Headlight

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 Kerr Corporation.

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
    63512
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0402-2013
  • Date de mise en oeuvre de l'événement
    2011-11-17
  • Date de publication de l'événement
    2012-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114097
  • 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
    Light, surgical headlight - Product Code EBA
  • Cause
    The firm recalled the freedom cordless led headlight because some units were assembled with an incorrect component in the control board electronics that may cause some freedom cordless led headlight units to become warm to the touch; however, no skin damage will occur.
  • Action
    Orascoptic sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 17, 2011. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return to the firm. Contact Orascoptic Customer Care at 608-831-2555 for assistance regarding this notice.

Device

Device Recall Surgical Headlight
  • Modèle / numéro de série
    Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470.   Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
  • Description du dispositif
    Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. || Freedom Cordless LED Light System is a Class I Medical Device. The device || listing number this product is E115952. || The intended use of this device is to illuminate oral structures and operating areas.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Adresse du fabricant
    Kerr Corporation, 3225 Deming Way, Middleton WI 53562
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA