CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
Transonic Flow Probe recalled by Transonic Systems
Transonic Systems is recalling Transonic Flow Probe, distributed nationwide in the US. The recall was initiated on 27 Jul 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-2722-2015
- FDA event ID
- 71907
- Recalling firm
- Transonic Systems, Ithaca, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2015
- FDA classified
- 2 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Jul 2015 | Recall initiated by company | |
| 2 Sep 2015 | Classified by FDA | +37 days |
| 9 Sep 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
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Questions about this recall
Is Transonic Flow Probe recalled?
Yes. Transonic Systems recalled Transonic Flow Probe on 27 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2722-2015.
Why was it recalled?
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.
Which lots are affected?
Serial Number: HQC6FMV2239
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Transonic Systems
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|---|---|---|---|---|---|
| Device | CLASS II | Transonic ADT1018 Flow QC Clear Advantage Tubing recalled | Transonic Systems | Sterility | Nationwide |
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| Device | CLASS II | Transonic Flow Probe recalled by Transonic Systems | Transonic Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Transonic Flow Probe recalled by Transonic Systems | Transonic Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Transonic Flow Probe recalled by Transonic Systems | Transonic Systems | Device Malfunction | Nationwide |
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