Events

Device Recall Clarisonic Skin Care System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pacific Bioscience Lab, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    44944
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0182-2008
  • 사례 시작날짜
    2007-07-03
  • 사례 출판 날짜
    2007-11-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64562
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Ultrasonic Cleaner -- Medical Instrument - Product Code FLG
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • 제조사 주소
    Pacific Bioscience Lab, Inc., 13222 Se 30th St Ste A1, Bellevue WA 98005
  • Source
    USFDA