Events

Device Recall Terumo Advanced Perfusion System 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems 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
    50554
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0910-2009
  • 사례 시작날짜
    2008-11-07
  • 사례 출판 날짜
    2009-02-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-07-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75750
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • 원인
    The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.
  • 조치
    An "Urgent Medical Device Correction" letter was sent to consignees on November 7, 2008. The letter described the reason for correction and provided instructions to customers. Terumo Cardiovascular Systems Corporation will replace the power manager boards on the affected devices. Customers were instructed to complete and fax the Customer Response Form to CVS Customer Service at 1-800-292-6551 (US only) or respond by telephone at 1-800-521-2818. Please direct questions to CVS Customers Service at 1-800-521-2818.

Device

Device Recall Terumo Advanced Perfusion System 1
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 0006 through 0066, 0100 through 0322, 1001 through 1027 and 1100 through 1161.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
  • 제품 설명
    Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within the United States). || The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA