Transonic Hemodialysis Monitor — Class II medical device recall Z-1295-2015
Terminated recall by Transonic Systems Inc, reported 2015-03-25, distributed nationwide. Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during di
| Recall number | Z-1295-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Transonic Systems Inc, Ithaca, NY, United States |
| Recall initiated | 2015-02-17 |
| Classified | 2015-03-18 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, KR |
| Serial numbers | HD03A60004, HD03A60020, HD03A70046, HD03A71082, HD03A71086, HD03A81167, HD03A81207, HD03A81225, HD03A81237, HD03A81240, HD03A91255, HD03A91258, HD03A91316, HD03A91338, HD03A91394, HD03A91406, HD03B01459, HD03B01461, HD03B01594, HD03B11667, HD03B11684, HD03B11705, HD03B21782, HD03B21803, HD03B21812 and 6 more |
| Model numbers | HD03 |
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.
Reason for recall
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).
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.