Food, drugs, devices › Transonic Systems Inc
Device recall: Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
FDA enforcement event 71907 is a device recall by Transonic Systems Inc of Ithaca, NY, initiated 27 Jul 2015 and classified Class II, with 10 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 18 Jul 2016. Initiation: voluntary: firm initiated. Transonic Systems Inc has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Transonic Systems Inc, Ithaca, NY.
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."
Distribution
"Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2720-2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively. | Domestic: 4 units | Class II | Terminated | 9 Sep 2015 |
| Z-2721-2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively. | Domestic: 36 units | Class II | Terminated | 9 Sep 2015 |
| Z-2722-2015 | Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively. | Domestic: 1 unit | Class II | Terminated | 9 Sep 2015 |
| Z-2723-2015 | Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively. | Domestic: 5 units | Class II | Terminated | 9 Sep 2015 |
| Z-2724-2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively. | Domestic: 6 units | Class II | Terminated | 9 Sep 2015 |
| Z-2725-2015 | Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively. | Domestic: 6 units | Class II | Terminated | 9 Sep 2015 |
| Z-2726-2015 | Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively. | Domestic: 8 units, foreign: 11 units | Class II | Terminated | 9 Sep 2015 |
| Z-2727-2015 | Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively. | Domestic: 35 units, Foreign: 12 units | Class II | Terminated | 9 Sep 2015 |
| Z-2728-2015 | Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively. | Domestic: 15 units, Foreign: 2 units | Class II | Terminated | 9 Sep 2015 |
| Z-2729-2015 | Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively. | Domestic: 2 units | Class II | Terminated | 9 Sep 2015 |
Context
Other enforcement events for Transonic Systems Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Feb 2018 | Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as par | Device | Class II | 1 |
| 17 Feb 2015 | Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained med | Device | Class II | 1 |
| 28 Mar 2013 | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status | Device | Class II | 1 |
All 4 events for Transonic Systems Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 Irrelevant Use Number."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Jul 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.