Device Recall System 1

  • Modèle / numéro de série
    catalog number: 802113 and serial numbers: 00007-00036, 00038-00045, 00047-00064, 00066-00077, 00080-00121, 00123-00214,00216-00283, 00285-00363, 00366-00498, 00500-00548, and 00550-00597.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
  • Description du dispositif
    Serial interface module RS-232 || Product Usage: || The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
  • 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

8 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    System 1000: serial numbers 1001S-1142S, 50001-52109, 01001-22223 Arena: serial numbers 300001-300640 1550: serial numbers 52599-67210 BM11: all serial numbers BM25: all serial numbers Meridian: serial numbers 200101-203156
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    This action covers Baxter''s complete line of hemodialysis hardware, which was distributed nationwide, including Puerto Rico, and internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Morocco, Malaysia, Netherlands, Oman, Panama, Peru, Philippines, Poland, Palestine, Romania, Russia, Saudia Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
  • Description du dispositif
    System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
  • Modèle / numéro de série
    product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX; all serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Canada, Korea, Hong Kong, Shanghai, Jamaica, Philippines, United Kingdom, Denmark, India, Belgium, Mexico, Italy, Austria, Sweden, Ecuador, Argentina, Brazil, Chile, Colombia, Peru, Turkey and Australia.
  • Description du dispositif
    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
  • Modèle / numéro de série
    product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2; all serial numbers within the range of 1001 through 22000
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including Puerto Rico, and internationally to Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Lebanon, Morocco, the Netherlands, Nigeria, Oman, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, UAE, UK, Turkey, Colombia, Dominican Republic, Trinidad, Jamaica, St. Croix, Brazil, Peru, Ecuador, Australia, Argentina, Paraguay, Uruguay, China, Korea, Taiwan, Philippines, India, Singapore, Malaysia, Thailand, Indonesia and Canada.
  • Description du dispositif
    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
  • Modèle / numéro de série
    MED. Serial Numbers: 400000 through 405499 are subject to correction.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
  • Description du dispositif
    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
  • Manufacturer
  • Modèle / numéro de série
    catalog number: 803518 and serial numbers:00007-00038, 00041, and 00043.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
  • Description du dispositif
    Serial interface module RS-485 || Product Usage: || The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
  • Manufacturer
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