Events

Device Recall Sarns " TCM II Temperature Control Module 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
    64530
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1569-2013
  • 사례 시작날짜
    2013-05-30
  • 사례 출판 날짜
    2013-06-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116407
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • 원인
    Internal testing found certain sarns" tcm ii systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
  • 조치
    Terumo sent beginning May 30, 2013, an URGENT MEDICAL DEVICE RECALL NOTIFICATION were sent to all customers with instructions to notify all customers of the recall requesting all affected units to be quarantined until the heatsink units are replaced Confirm receipt by filling out the response form containing communication by faxing or emailing the attached Affiliate Response Form to the fax number or email address indicated on the form. Questions should be directed to Terumo CVS customer service in the U.S.: Telephone: +1-734-663-4145; Fax: +1-734-741-6149

Device

Device Recall Sarns " TCM II Temperature Control Module
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 4416 and Serial Numbers: 4656, 4657, 4658,4659, 4661, 4662, and 4663.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including the countries of UAE (United Arab Emirates) HONG KONG and THAILAND. Not distributed in USA
  • 제품 설명
    Sarns " TCM II Temperature Control Module || The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature
  • 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