Events

Retiro De Equipo (Recall) de Device Recall Laser Handpiece

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 Beijing Syntech Laser Co., Ltd.

¿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
    79697
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1488-2018
  • Fecha de inicio del evento
    2017-07-03
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163045
  • 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
    Powered laser surgical instrument - Product Code GEX
  • Causa
    The noncompliance is that the certification label was not affixed on the product, with statement "complies with 21 cfr 1040.10 and 1040.11 except for deviations pursuant to laser notice no. 50, dated june 24, 2007".
  • Acción
    Beijing Syntech Laser measures to be taken: 1. Beijing Syntech Laser Co. Ltd. has sent notifications to all relevant dealers, distributors, and purchasers, 2. Beijing Syntech Laser Co. Ltd. will send certification labels and instructions to apply the label to the product to all relevant dealers, distributors, and purchasers, 3. The corrections will be conducted at no cost to the purchaser, and 4.The corrective action will be completed by August 1st, 2018. 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, if it hasnt been already. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions please call (360) 325-7028

Device

Device Recall Laser Handpiece

Manufacturer

Beijing Syntech Laser Co., Ltd
  • Dirección del fabricante
    Beijing Syntech Laser Co., Ltd, International Industry Base, West Area F/4; No. 8 Liye Road; Changping, Beijing China
  • Empresa matriz del fabricante (2017)
    Beijing Syntech Laser Co. Ltd.
  • Source
    USFDA