Device Recall Terumo HX2 Temperature Management System

  • Model / Serial
    HX2 Temperature Management System, 120V  Catalog # 809810  serial numbers: 00016, 0001  1116  HX2 Temperature Management System, 100V Catalog # 812231  serial numbers: 0001, 1002, PT0003, PT0004   HX2 Temperature Management System, 240V Catalog # 812240  serial numbers: 0001, 0002  HX2 Temperature Management System, Trial Kit Catalog # 809810TK  serial numbers: 1001  1042
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.
  • Product Description
    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    All Lot Codes
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
  • Product Description
    Terumo HX2 Temperature Management System, Catalog No. 809810 || The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
  • Manufacturer
  • Model / Serial
    Serial numbers 0001-0003, 1001-1084 and 1101-1116.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: AR, CA, CO, CT, FL, HI, IA, IL, KS, LA, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA and WI.
  • Product Description
    Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. || The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.
  • Manufacturer