Z-1295-2015Class II

Transonic Hemodialysis Monitor, Model HD03 --

Name: Z-1295-2015 Transonic Hemodialysis Monitor, Model HD03 --
Creator: Transonic Systems Inc
Published: 2015-02-17
License: https://open.fda.gov/license/

Transonic Systems Inc / initiated 2015-02-17 / Terminated / root cause: manufacturing process

FDA source

Transonic Systems Inc began a recall of Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered... on 2015-02-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1295-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Posted: 2015-03-18
Terminated: 2016-05-31
Recalling firm: Transonic Systems Inc
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.
Product code: MQS System, Hemodialysis, Access Recirculation Monitoring
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Transonic sent a Medical Device Recall Letters and Response Forms dated February 17, 2015 to the users via e-mail and fax. The recall is being conducted to the user level. The letter identified the affected product, problem and actions to be taken. For questions call 607-257-5300 ext. 326.
Quantity in commerce: Domestic: 21 units, Foreign: 10 units
Distribution: Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1295-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1295-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-18

Product code MQS

K960817Class IIHd01-Series Transonic Hemodialysis Monitor (R%,qa,co,qb,qb2)Transonic Systems, Inc. / cleared 1997-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)