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Transonic Systems Inc recalls Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trai
Recalled March 25, 2015 · FDA recall Z-1295-2015 · Transonic Systems
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). · FDA Class II
Units
Domestic: 21 units, Foreign: 10 units
Sold at
Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
Description
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).
Product
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(s)
Transonic Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →