Events

Rappel de Device Recall LuxStar Dental Light

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
    59099
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2834-2011
  • Date de mise en oeuvre de l'événement
    2011-05-27
  • Date de publication de l'événement
    2011-07-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101128
  • 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, operating, dental - Product Code EAZ
  • Cause
    Lens heat shield (birdcage) of the luxstar dental light could fall and injure a patient.
  • Action
    Dental Equipment, LLC sent an "URGENT MEDICAL DEVICE RECALL" notification letter via USPS 1st class to US consignees and via Federal Express or Fax to foreign consignees on June 24, 2011. The letter informed customers about the product, problem and tether upgrade corrective action. A Field Correction Acknowledgement Form and the Field Correction Completion Form was attached for customers to complete and return via the fax number 503-537-3617. The letter states that customers are to review their records in order to identify where the affected devices are located and which are still in service. Customers can call the Customer Service at 800-304-5332 and order the self-install Upgrade Kits with the Part Number 30792 at no charge. Customers are instructed to complete the Rework Correction Form once all of the lights have been updated and fax or mail to Marcus, attention Bonnie Dundas, at (503) 537-3617.

Device

Device Recall LuxStar Dental Light
  • Modèle / numéro de série
    LuxStar Dental Light does not have Serial Number. They are identified by Catalog Model numbers such as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of: CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico and the countries of: Australia, Belgium, Canada, France, Germany, Ireland, Italy, Mexico, Norway, Poland, Russia, United Kingdom, Vietnam, and Trinidad.
  • Description du dispositif
    LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. || The product is labeled in part: " Marus Dental***Mfg By: Dental Equipment LLC.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***". || Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures.
  • 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