Transonic Systems Inc recalls Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained me…

Recall date

February 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1295-2015

FDA classification

Class II

Brand / firm

Transonic Systems Inc

Sold / distributed

Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.