FDAFebruary 17, 2015device
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 recall recorded by the U.S. Food & Drug Administration.
The 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).
What to do
FDA enforcement status: Terminated
Brands named
transonic systemstransonic
Recall history
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