Events

Device Recall NonCertified laser diode component 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ii - Vi Incorporated 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
    80020
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1614-2018
  • 사례 시작날짜
    2017-12-13
  • 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=164228
  • 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
    unknown device name - Product Code N/A
  • 원인
    Affected diodes incorporated in the laser sights emitted greater than the 5 mw limit.
  • 조치
    Please note that II-VI Inc. is responsible for the correction of all noncompliant products should the reported epoxy processing defect adversely affect any other laser diodes manufactured by II-VI, Inc. The single customer, Crimson Trace Corporation CTC was formally notified by you in writing. The defective laser diodes, models 25-0655 & 25-0657 will be or have already been replaced at no cost to CTC. The replacement will be done in batches and is expected to take approximately six to nine months, or no later than January 31, 2019. Defective laser diodes will be either returned to II-VI or destroyed at CTC. For further questions, please call (724) 352-4455.

Device

Device Recall NonCertified laser diode component
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 25-0655 & 25-0657
  • 유통
    US Distribution to Oregon.
  • 제품 설명
    11-VI Incorporated Laser diode component || Non-certified laser diode component used in laser sights for firearms
  • Manufacturer
    Ii - Vi Incorporated

Manufacturer

Ii - Vi Incorporated
  • 제조사 주소
    Ii - Vi Incorporated, 375 Saxonburg Blvd, Saxonburg PA 16056-9430
  • 제조사 모회사 (2017)
    II-VI, Inc.
  • Source
    USFDA