FDA-Device2015-03-25Class II
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.
Transonic Systems Inc
Hazard
Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
Sold states
Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
Affected count
Domestic: 21 units, Foreign: 10 units
Manufactured in
34 Dutch Mill Rd, Warren Road Business Park, Ithaca, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2015Don't want to check this manually?
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