CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report
Transonic Hemodialysis Monitor recalled by Transonic Systems
Transonic Systems is recalling Transonic Hemodialysis Monitor, distributed nationwide in the US. The recall was initiated on 17 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1295-2015
- FDA event ID
- 70647
- Recalling firm
- Transonic Systems, Ithaca, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2015
- FDA classified
- 18 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Feb 2015 | Recall initiated by company | |
| 18 Mar 2015 | Classified by FDA | +29 days |
| 25 Mar 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
Questions about this recall
Why was it 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).
Which lots are affected?
Serial Numbers HD03A60004; HD03A81167; HD03A81225; HD03A81237; HD03A91338; HD03A91394; HD03A91406; HD03B01461; HD03B21782; HD03B21803; HD03A60020; HD03A71082; HD03A81207; HD03A91255; HD03A91316; HD03Bl1679; HD03B11684; HD03B11705; HD03B21812; HD03B31971; HD03A81240; HD03A71086; HD03B01459; HD03B01594; HD03B11667; HD03B42175; HD03B42160; HD03B42161; HD03A91258; HD03A70046; HD03B31901
Where was it sold?
Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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