Device Recall Terumo Advanced Perfusion System 1

  • Modèle / numéro de série
    Catalog Number: 801763 and Serial Numbers: 0011-0335,0337-0610,1001- 1034,1037-1049,1100,1103-1106,1109-1445, and 1447-1450.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. 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, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
  • Source
    USFDA

40 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog Number 801763
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Terumo¿ Advanced Perfusion System 1 || 100/120V AC, Advanced Perfusion System || Platform (APS)
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 801764
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Terumo¿ Advanced Perfusion System 1 || 220/240V AC, Advanced Perfusion System || Platform (APS)
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1310, 1358, 2322, 2325, 2327, 2328 and 2330 through 2333.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.
  • Description du dispositif
    Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. || The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal 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
  • Modèle / numéro de série
    Serial numbers 0030, 0032 through 0587, 0700 through 1527, 1529, 1531 through 1533, 1563 through 1569, 1572, 1575, 1577 through 1581, 1584 through 1587, 1607, 2230 through 2235, 2239 through 2242, 2581 through 2583 and 2587 through 2594.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam.
  • Description du dispositif
    Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. || The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal 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
  • Modèle / numéro de série
    Serial Numbers: 0011 through 0610, 1001 through 1034, 1037 through 1049, 1100 and 1103 through 1174.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, 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 and Viet Nam.
  • Description du dispositif
    Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. || The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist.
  • Manufacturer
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