Class II — Transonic Systems Inc
| Recalling firm | TRANSONIC SYSTEMS, INC. |
|---|---|
| Registered facility | TRANSONIC SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | Domestic: 21 units, Foreign: 10 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea |
| Initiated | 2015-02-17 |
| Classified | 2015-03-18 |
| Terminated | 2016-05-31 |
| Recall number | Z-1295-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Transonic Systems Inc (Z-1295-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70647/
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