Cynosure 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cynosure, 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
    69463
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0169-2015
  • 사례 시작날짜
    2014-10-09
  • 사례 출판 날짜
    2014-11-04
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-03-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    If the laser system is turned on and the user adjusts, installs or removes the xpl pulsed light handpiece, there is a potential risk of an electrical shock.
  • 조치
    Cynosure sent an Urgent Medical Device Recall Notification dated October 9, 2014, to all affected customers. They were also notified by phone. The letter identified the product the problem and the action needed to be taken by the customer. There are two methods for returning the Elite XPL handpieces. If the handpiece is NOT currently connected to the laser console, the customer will be asked to return it to the Cynosure office. If the handpiece is not connected there is no risk. If the handpiece is currently connected to the laser console, the customer is instructed to immediately discontinue use of the laser system and to turn off the system immediately. They are also being instructed to leave the handpiece attached to the console and to not touch it. A Cynosure Field service engineer will then come to the office and remove the handpiece and return it to the Cynosure factory. In addition, the Cynosure Field Service engineer will install an interlock into the connector receptacle on the laser console. This interlock plug is an existing component that is used on systems that do not have an IPL handpiece in place. If your XPL pulsed light handpiece is not attached to the laser system please call Cynosure customer service (1-877-222-6822) to arrange for the handpiece to be returned and repaired.

Device

  • 모델명 / 제조번호(시리얼번호)
    All Serial numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK.
  • 제품 설명
    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cynosure, Inc., 5 Carlisle Rd, Westford MA 01886
  • 제조사 모회사 (2017)
  • Source
    USFDA