Z-2721-2015Class II

Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC --

Name: Z-2721-2015 Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC --
Creator: Transonic Systems Inc
Published: 2015-07-27
License: https://open.fda.gov/license/

Transonic Systems Inc / initiated 2015-07-27 / Terminated / root cause: software

FDA source

Transonic Systems Inc began a recall of Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively on 2015-07-27. FDA classified it as Class II and gives the reason as "Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2721-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Posted: 2015-09-03
Terminated: 2016-07-18
Recalling firm: Transonic Systems Inc
Product: Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
Product code: DPW Flowmeter, Blood, Cardiovascular
Reason for recall: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately.
Quantity in commerce: Domestic: 36 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Product codes and lots: Serial Numbers: HQC3FMC2501, HQC3FMC2502, HQC3FMC2503, HQC3FMC2504, HQC3FMC2505, HQC3FMC2506, HQC3FMC2507, HQC3FMC2508, HQC3FMC2509, HQC3FMC2510, HQC3FMC2511, HQC3FMC2512, HQC3FMC2513, HQC3FMC2514, HQC3FMC2515, HQC3FMC2516, HQC3FMC2517, HQC3FMC2518, HQC3FMC2519, HQC3FMC2520, HQC3FMC2521, HQC3FMC2522, HQC3FMC2523, HQC3FMC2524, HQC3FMC2525, HQC3FMC2526, HQC3FMC2527, HQC3FMC2528, HQC3FMC2529, HQC3FMC2530, HQC3FMC2531, HQC3FMC2532, HQC3FMC2533, HQC3FMC2534, HQC3FMC2535, HQC3FMC2636

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2721-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2720-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2721-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2722-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2723-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2724-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2725-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2726-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2727-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2728-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2729-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02

Product code DPW

K872048Class IITransonic FlowmeterTransonic Systems, Inc. / cleared 1988-06-21

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)