Events

Rappel de Device Recall Denlase: Diode Laser Therapy System and Penlase Dental Laser Therapy 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 China Daheng Group 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
    67520
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1145-2014
  • Date de mise en oeuvre de l'événement
    2013-07-15
  • Date de publication de l'événement
    2014-03-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125664
  • 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
    Laser, Dental - Product Code LYB
  • Cause
    Failure to provide calibration procedures to purchasers, as required by 21 cfr 1040.11(a)(2). for example, the user manual did not contain calibration procedures for denlase or penlase lasers.
  • Action
    China Daheng Group, lnc.(CDH}, ensures tha they will execute seriously their plans for the repair of their electronics products Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System. China Daheng Group, lnc.(CDH}, will send their updated 238 pes of Diode Laser Therapy System operation manual and 200 pes of Dental soft Tissue Laser brochure to their Distributor. They will pay all of their expense including manufacture cost and freight cost. China Daheng Group, lnc.(CDH}, will remedy these defects through changing the manuals and brochures for their distributor, purchasers and any subsequent transferee. They will make new version manuals and brochures. Then they will send them to their customers and distributor after finishing inspection by their quality department according to the procedure Denlase-Y0029A for manual and brochure inspection. CDRH approves the CAP subject to the following condition: .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.

Device

Device Recall Denlase: Diode Laser Therapy System and Penlase Dental Laser Therapy System
  • Modèle / numéro de série
    Denlase and Penlase Dental Laser Systems.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
  • Description du dispositif
    Denlase: Diode Laser Therapy System and Penlase: || Dental Laser Therapy System surgical powered. || Surgical powered Laser instruments.
  • Manufacturer
    China Daheng Group Inc.

Manufacturer

China Daheng Group Inc.
  • Adresse du fabricant
    China Daheng Group Inc., #A9 Shangdi Xinxilu, Haidian District, Beijing China
  • Société-mère du fabricant (2017)
    China Daheng Group Inc.
  • Source
    USFDA