Device Recall Terumo Advanced Perfusion System 1

  • 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
  • 1 Event

Fabricant

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

40 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
  • Description du dispositif
    Flowmeter Module (accessory to Terumo Advanced || Perfusion System 1). || Provides the interface between the flow sensor and the system.
  • Manufacturer
  • Modèle / numéro de série
    Catalog number 816571 (Serial Number 5315)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog number 801041 (Serial Numbers 0216, 0233, 0354, 0800,and 2588)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog number 801040 (Serial Numbers 0138, 0708, and 0735)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Description du dispositif
    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
  • 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) 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.
  • Description du dispositif
    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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