Rappel de Decade Plus 1221 Dental Chair

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 A-Dec 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
    52039
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0541-2011
  • Date de mise en oeuvre de l'événement
    2009-04-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2010-12-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    chair, dental, with operative unit - Product Code KLC
  • Cause
    The design of the decade plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.
  • Action
    A-dec sent a letter dated March 23, 2009 to consignees/customers (doctors and network dealers). The consignees were informed that the design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests. The potential for this occurs when returning the chair to the upright position. The consignees were advised to reprogram the Position 0/Entry-Exit preset to stop the back before it reaches a full upright position. This increases the gap between the armrest and the back slightly. To reprogram a chair, the firm included excerpts from a chair Instructions for Use (IfU) guide that detail the steps to reprogram a chair. Consignees can contact the firm's Customer Service at 503-538-9471, 1-800-547-1883, or via fax at 503-538-0276. The firm will replace the chair back assembly for all affected dental chairs.

Device

  • Modèle / numéro de série
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  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US and Canada.
  • Description du dispositif
    A-dec Decade Plus 1221 Dental Chair || This chair is used for positioning dental patient prior to and during dental treatment.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    A-Dec Inc, 2601 Crestview Dr, Newberg OR 97132
  • Société-mère du fabricant (2017)
  • Source
    USFDA