Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Transonic Hemodialysis Monitor Recalled by Transonic Systems Inc Due to Customer unable to obtain measurements due to the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Transonic Systems Inc directly.
Affected 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.
Quantity: Domestic: 21 units, Foreign: 10 units
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Transonic Systems Inc
Transonic Systems Inc has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report