Device Recall Transonic Hemodialysis Monitor

  • Model / Serial
    Serial Numbers HD03A60004; HD03A81167; HD03A81225; HD03A81237; HD03A91338; HD03A91394; HD03A91406; HD03B01461; HD03B21782; HD03B21803; HD03A60020; HD03A71082; HD03A81207; HD03A91255; HD03A91316; HD03Bl1679; HD03B11684; HD03B11705; HD03B21812; HD03B31971; HD03A81240; HD03A71086; HD03B01459; HD03B01594; HD03B11667; HD03B42175; HD03B42160; HD03B42161; HD03A91258; HD03A70046; HD03B31901
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
  • Product Description
    Transonic Hemodialysis Monitor, Model HD03 -- || Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Transonic Systems Inc, 34 Dutch Mill Rd, Warren Road Business Park, Ithaca NY 14850-9785
  • Manufacturer Parent Company (2017)
  • Source
    USFDA