Events

Rappel de Device Recall Dental chair headrest

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 Dental Equipment LLC.

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
    55153
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2241-2010
  • Date de mise en oeuvre de l'événement
    2010-03-23
  • Date de publication de l'événement
    2010-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90151
  • 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
    Dental chair headrest - Product Code NRU
  • Cause
    The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.
  • Action
    DCI Equipment sent an "Urgent Field Safety Alert" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.

Device

Device Recall Dental chair headrest
  • Modèle / numéro de série
    The individual headrests do not have serial numbers. The headrest has a part number of "40R501". The part number is followed by a dash and a 2 or 3 digit number that indicates the color of the vinyl covering.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution in the USA and Canada.
  • Description du dispositif
    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): || The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: || Marus MaxStar-Agency Model # DC1490; || Marus MaxStar-Agency Model # DC1690; || Marus NuStar-Agency Model # DC1700; || Marus NuStar-Agency Model # DC1702; || Marus ProStar-Agency Model # DC1540; || Marus ProStar-Agency Model # DC1535; || DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and || DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • Adresse du fabricant
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA