Events

Device Recall Laser Handpiece 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beijing Syntech Laser Co., Ltd 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
    79697
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1488-2018
  • 사례 시작날짜
    2017-07-03
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163045
  • 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
    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".
  • 조치
    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
  • 제조사 주소
    Beijing Syntech Laser Co., Ltd, International Industry Base, West Area F/4; No. 8 Liye Road; Changping, Beijing China
  • 제조사 모회사 (2017)
    Beijing Syntech Laser Co. Ltd.
  • Source
    USFDA