Events

Terumo APS 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corp 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
    36396
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-324-2007
  • 사례 시작날짜
    2004-10-12
  • 사례 출판 날짜
    2006-12-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48576
  • 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
    Perfusion System - Product Code DTQ
  • 원인
    Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'x' being displayed on the monitor screen.
  • 조치
    U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Device

Terumo APS 1
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0031, 0032, 0034 through 0041, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0071 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0095, 0097 through 0099, 0101 through 0105, 0107, 0108, 0110, 0111, 0113 through 0117, 0120-0123, 0125-0131, 0133-0135, 0137 through 0140, 0142 through 0165, 0167 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0204, 0206, 0207, 0209, 0211 through 0235, 0237 through 0250, 0252 through 0291, 0293 through 0437, 0440 through 0522, 0524 through 0527, 0700 through 0725, 0727, 0730 through 0858, 0860 through 0878, 0880, 0881, 0885 through 0903, 0906 through 0912, 0922 and 0924.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
  • 제품 설명
    Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • 제조사 주소
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA