Events

Device Recall Evolution steam sterilizers 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
    61786
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1522-2012
  • 사례 시작날짜
    2012-03-23
  • 사례 출판 날짜
    2012-05-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109080
  • 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, steam - Product Code FLE
  • 원인
    Through customer feedback and field service experience, steris learned that operators may experience difficulty when inserting or removing equipment from the evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) the rollers on the ends of the pivot a.
  • 조치
    Steris Corporation sent an Urgent Voluntary Field Correction Notice dated March 23, 2012 via FedEx with tracking numbers for delivery confirmation to each affected customer. The letter identified the affected product, problem and actions to be taken. The letter stated a STERIS Field Service Representatives will contact each affected customer to schedule a service visit to upgrade the transfer carriages. For technical questions or questions regarding STERIS visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Device Recall Evolution steam sterilizers
  • 모델명 / 제조번호(시리얼번호)
    Model #: M4012097, M4012098, M4011084, M4011085 & M4011090; Seral #s: 030400905 thru 030381235.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including AL, AZ, CA, CO, CN, DE, FL, GA, IL, IN, KA, KY, LA, MD, MA, MI, ME, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, & WY and the countries of Brazil and Canada.
  • 제품 설명
    The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: || -Loading Car: Shelving unit which holds the items to be sterilized; and the || -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. || Product Usage: || The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • 제조사 주소
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • 제조사 모회사 (2017)
    Steris Corporation
  • Source
    USFDA