Device Recall Terumo HX2 Temperature Management System

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 0001-0003, 1001-1084 and 1101-1116.
  • 의료기기 분류등급
  • 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
  • 1 Event

제조사

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

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  • 모델명 / 제조번호(시리얼번호)
    HX2 Temperature Management System, 120V  Catalog # 809810  serial numbers: 00016, 0001  1116  HX2 Temperature Management System, 100V Catalog # 812231  serial numbers: 0001, 1002, PT0003, PT0004   HX2 Temperature Management System, 240V Catalog # 812240  serial numbers: 0001, 0002  HX2 Temperature Management System, Trial Kit Catalog # 809810TK  serial numbers: 1001  1042
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.
  • 제품 설명
    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Lot Codes
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
  • 제품 설명
    Terumo HX2 Temperature Management System, Catalog No. 809810 || The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
  • Manufacturer