Events

Device Recall Fixed eye Safety filters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Laserex Systems 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
    73468
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1270-2016
  • 사례 시작날짜
    2016-02-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144247
  • 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
    Laser, ophthalmic - Product Code HQF
  • 원인
    The firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
  • 조치
    Ellex Medical Pty Ltd. Planned Action to bring into Compliance: 1.Field Corrective Action replacing all affected safety filters of all units manufactured between July 2012 and February 2016, 2.All repairs will be made at no cost to the purchaser; and 3.The corrections will be completed by March 30, 2017. CDRH approves the CAP subject to the following conditions: 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. For further questions please call (800) 824-7444.

Device

Device Recall Fixed eye Safety filters
  • 모델명 / 제조번호(시리얼번호)
    Model Number : 3143270
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution
  • 제품 설명
    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. || The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. || .
  • Manufacturer
    Laserex Systems Inc.

Manufacturer

Laserex Systems Inc.
  • 제조사 주소
    Laserex Systems Inc., 7138 SHADY OAK RD, EDEN PRAIRIE MN 55344-3517
  • Source
    USFDA