Device Recall Terumo Advanced Perfusion System 1

  • Model / Serial
    serial numbers 0011-0610, 1001-1182.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, ME, MI, MO, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and the countries of CANADA, COLUMBIA, JAPAN, RUSSIA, EGYPT, TURKEY, PAKISTAN, KUWAIT, COSTA RICA, TAIWAN, SAUDI ARABIA, INDIA, SOUTH KOREA, JORDAN, THE PHILLIPINES, INDONESIA, HONDURAS, DOMINICAN REPUBLIC, REPUBLIC OF GEORGIA, HONG KONG, UNITED ARAB EMIRATES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, GERMANY, BELGIUM, MEXICO, THAILAND, VEITNAM, SOUTH AFRICA
  • Product Description
    Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. || The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

40 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog number: 801763
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in 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, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA
  • Product Description
    100/120V AC, Advanced Perfusion System 1 || Product Usage: || The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
  • Manufacturer
  • Model / Serial
    Catalog Number or Part Number: 801763  Description: 100/120V AC, Advanced Perfusion System 1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA
  • Product Description
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) || 100/120V AC || Product Usage: || The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
  • Manufacturer
  • Model / Serial
    Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA
  • Product Description
    Terumo¿ Advanced Perfusion System 1 (APS1, System 1) || Description: 220/240V AC || Product Usage: || The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
  • Manufacturer
  • Model / Serial
    Catalog number: 801764
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in 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, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA
  • Product Description
    220/240V AC, Advanced Perfusion System 1 || Product Usage: || The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
  • Manufacturer
  • Model / Serial
    Catalog Number 801763
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, 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, and the countries of AUSTRALIA, BELGIUM, CANADA, CHILE, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Product Description
    Terumo¿ Advanced Perfusion System 1 || 100/120V AC, Advanced Perfusion System || Platform (APS)
  • Manufacturer
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