Device Recall Terumo Advanced Perfusion System 1

  • Modèle / numéro de série
    serial numbers 1001-6903
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Large Roller Pump 6" Diameter, Catalog 816571, 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
  • 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

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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 the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
  • Description du dispositif
    Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 || 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
  • Modèle / numéro de série
    Catalog number: 801764
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
  • Description du dispositif
    Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 || 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
  • Modèle / numéro de série
    Catalog number: 801763
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog Number or Part Number: 801763  Description: 100/120V AC, Advanced Perfusion System 1
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog Number or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
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