Events

Device Recall 100/120V AC, Advanced Perfusion System Platform (APS) 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
    63543
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0435-2013
  • 사례 시작날짜
    2012-11-14
  • 사례 출판 날짜
    2012-11-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114179
  • 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
    Terumo cardiovascular system (tcvs) has received reports of a situation where users experienced a total loss of functionality for some system 1 units. the reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. the result is all pumps stop, with no safety system functionality, and the battery would not be activated. the user would be limi.
  • 조치
    Terumo Cardiovascular Systems sent a Urgent Medical Device Recall Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Terumo CVS is alerting all users of Terumo System 1 of the reports of malfunction. Customers were instructed to: 1. Review this Medical Device Safety Advisory. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/email address indicated on the form. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818, Recall Fax 1-734-741-6149 Customer Service Hours: Monday thru Friday, 8 AM - 6 PM ET

Device

Device Recall 100/120V AC, Advanced Perfusion System Platform (APS)
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 801763 and all serial numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.
  • 제품 설명
    100/120V AC, Advanced Perfusion System Platform (APS) || The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • 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