Device Recall Terumo Advanced Perfusion System 1

  • Model / Serial
    serial numbers 006-0322, 1001-1173.
  • 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, 220/240V System 1 Base, REF 801764, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. (not sold in the USA) || 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 # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
  • Product Description
    Flowmeter Module (accessory to Terumo Advanced || Perfusion System 1). || Provides the interface between the flow sensor and the system.
  • Manufacturer
  • Model / Serial
    Catalog number 816571 (Serial Number 5315)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Product Description
    Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) || Product Usage: 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
  • Model / Serial
    Catalog number 801041 (Serial Numbers 0216, 0233, 0354, 0800,and 2588)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Product Description
    Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 || Product Usage: 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
  • Model / Serial
    Catalog number 801040 (Serial Numbers 0138, 0708, and 0735)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Product Description
    Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 || Product Usage: 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
  • Model / Serial
    Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), and Vietnam.
  • Product Description
    Central Control Module for System 1: System 1 Base, 100/120V || 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
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