Events

Retiro De Equipo (Recall) de Device Recall Clarisonic Skin Care 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 Pacific Bioscience Lab, 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
    44944
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0182-2008
  • Fecha de inicio del evento
    2007-07-03
  • Fecha de publicación del evento
    2007-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64562
  • 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
    Ultrasonic Cleaner -- Medical Instrument - Product Code FLG
  • Causa
    Overheating: the handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.
  • Acción
    On August 30, 2007, the firm issued a press statement via PR Newswire and The Associated Press. They also posted a Recall Notice on their website (www.Clarisonic.com) requesting consumers to return their affected products for an exchange. All retailers and professional resellers were notified by telephone, E mail and/or letter and asked to return unsold inventory, as well as, post the provided point of sales notices and send provided post cards to known customers requesting exchange of recalled product. All users can contact the firm via the website or by phone at 1-866-378-7360 (6 am-6pm, M-F, Pacific Time) to arrange for the device exchange.

Device

Device Recall Clarisonic Skin Care System
  • Modelo / Serial
    All codes prior to 07177xx. (June 26, 2007). Lot codes are as follows: YYDDDxx, where DDD is the ordinal date. Handle codes are clearly printed on the bottom of the handle. All codes lot codes after, and including 07177xx are not subject to recall, and are followed by a "T" or "J" for ease in identification
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - including USA and countries of Japan and Canada. Units were distributed to retailers and professional skin care clinics throughout the USA. In addition, units were distributed to one distributor in Japan and to 4 clinics in Canada.
  • Descripción del producto
    Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005
  • Manufacturer
    Pacific Bioscience Lab, Inc.

Manufacturer

Pacific Bioscience Lab, Inc.
  • Dirección del fabricante
    Pacific Bioscience Lab, Inc., 13222 Se 30th St Ste A1, Bellevue WA 98005
  • Source
    USFDA