Events

Device Recall Terumo HX2 Temperature Management System 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
    55224
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2060-2010
  • 사례 시작날짜
    2010-06-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90368
  • 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
    The hx2 temperature management system mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode.
  • 조치
    The firm, TERUMO Cardiovascular Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 11, 2010, to the consignees. The letter describes the product, reason for correction, what to do in the event of failure, potential hazard, correction, affected population and action to be taken by the customers. The customers are instructed to review the correction notice, assure that all users are aware of this notice, and complete, sign and fax the attached Customer Response Form to Terumo CVS Customer Service at 800-292-6551. The Terumo CVS Customer Service Dept. will contact you upon receipt of the Customer Response Form to schedule the replacement. The firm plans to inspect and correct all units in the field within 5 months. We encourage you to contact Terumo CVS Customer Service at 1-800-521-2818, Monday-Friday, 8 AM-6 PM EST, with any questions or concerns.

Device

Device Recall Terumo HX2 Temperature Management System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0001-0003, 1001-1084 and 1101-1116.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: AR, CA, CO, CT, FL, HI, IA, IL, KS, LA, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA and WI.
  • 제품 설명
    Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. || The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.
  • 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