Device Recall Terumo Advanced Perfusion System 1

  • Modelo / Serial
    catalog number: 801188 and Serial numbers: 0001-0006, 0008-00050, 00052-00123,00125-00152, 00154-0174,00176-00211, 00213-00241, 00245-00250, 00300-00356, 00358-00365, 00367-00449, 00451-00489, 00492-00522, 00524-00531, 00533-00649, 00651-00660, 00662-00825,0826-0830, 00831-01157, and 01160-01164.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of 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.
  • Descripción del producto
    Terumo Advanced Perfusion System 1 || Electronic O2 Blender/Analyzer. || The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

40 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    01198, 01205-01241, 01243-01281, 01283-01399, 01401-01404, 01406-01422, 01424-01433, 01435-01554, 01556-01564, 01565-01581, 01583-01609, 01611, 01613-01660, 01662-01721, 01724-01725.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
  • Descripción del producto
    Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit.
  • Manufacturer
  • Modelo / Serial
    00632-00635, 00638, 00642-00711, 00713-00715, 00717-00741, 00752-00813, 00815-00821, 00823-00864, 00867, 00869-00874.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam
  • Descripción del producto
    Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. || The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
  • Manufacturer
  • Modelo / Serial
    serial numbers 0011-0610, 1001-1182.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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
  • Modelo / Serial
    serial numbers 006-0322, 1001-1173.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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
  • Modelo / Serial
    serial numbers 0011-1438.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and the countries of Argentina, Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Jordan, Korea, Kuwait, Malaysia, Mexico, Pakistan, Republic of Georgia, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, The Phillipines, Turkey, United Arab Emirates and Vietnam.
  • Descripción del producto
    System 1 Base 110V, Catalog 801763, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI || The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional
  • Manufacturer
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