Events

APL Valve used on some Fabius GS, Fabius Tiro and Narkomed 6000 series Anesthesia Machines 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draeger Medical, 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
    30284
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0192-05
  • 사례 시작날짜
    2004-09-15
  • 사례 출판 날짜
    2004-11-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35610
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • 원인
    Rotating knob of the rotary style apl valve can become separated from the assembly.
  • 조치
    The recalling firm issued a letter to their accounts informing them of the problem. The letter also informed the accounts that they would be contacted when the replacement knob was available to schedule the correction.

Device

APL Valve used on some Fabius GS, Fabius Tiro and Narkomed 6000 series Anesthesia Machines
  • 모델명 / 제조번호(시리얼번호)
    APL Valve part number MK00625
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was shipped to medical supply companies, medical facilities nationwide. The product was also shipped to a government accounts in AR, FL, ID, LA, MA, MD, ME, NC, NY, OH, TX, VA, and VT. The product was also shipped to Canada, Germany, Korea, China, Australia, Singapore, Switzerland, and England
  • 제품 설명
    APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • 제조사 주소
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA