Events

Device Recall Reliance EPS Endoscope Processing System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Steris Corporation 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
    56245
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0823-2011
  • 사례 시작날짜
    2010-07-02
  • 사례 출판 날짜
    2010-12-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93052
  • 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
    Sterilizer, chemical - Product Code MLR
  • 원인
    Reliance eps had internal water leaks and interrupted cycles when air leaks triggered false fault 38 alarm that dg/hld cup has not been replaced.
  • 조치
    Steris issued an "Urgent Field Correction Notice" dated July 2, 2010 to each affected US consignee, notifying them of the issue and affected device. Steris Field Service Representatives and Dealers will contact each affected customer to schedule a service visit to install system upgrades. In the event of an interrupted cycle prior to the upgrade, consignees were instructed that the load should be handled in accordance with the Reliance EPS Operators Manual. Steris can be contacted at 440-392-7043.

Device

Device Recall Reliance EPS Endoscope Processing System
  • 모델명 / 제조번호(시리얼번호)
    Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom.
  • 제품 설명
    Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. || Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • 제조사 주소
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • 제조사 모회사 (2017)
    Steris Plc
  • Source
    USFDA