Events

Retiro De Equipo (Recall) de Device Recall Denlase: Diode Laser Therapy System and Penlase Dental Laser Therapy System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por China Daheng Group Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67520
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1145-2014
  • Fecha de inicio del evento
    2013-07-15
  • Fecha de publicación del evento
    2014-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125664
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Laser, Dental - Product Code LYB
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Denlase and Penlase Dental Laser Systems.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
  • Descripción del producto
    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.
  • Dirección del fabricante
    China Daheng Group Inc., #A9 Shangdi Xinxilu, Haidian District, Beijing China
  • Empresa matriz del fabricante (2017)
    China Daheng Group Inc.
  • Source
    USFDA