Data Foundry

Medical device recalls 2015

Transonic Flow Probe — Class II medical device recall Z-2727-2015

Terminated recall by Transonic Systems Inc, reported 2015-09-09, distributed nationwide. Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from

Recall numberZ-2727-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTransonic Systems Inc, Ithaca, NY, United States
Recall initiated2015-07-27
Classified2015-09-02
Reported by FDA2015-09-09
Terminated2016-07-18
DistributedNationwide (US)
Countries outside the USCA, JP, NL, RU
Reason classessoftware
Serial numbersHQD3FMC3763, HQD3FMC3764, HQD3FMC3765, HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770, HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775, HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780, HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785, HQD3FMC3786, HQD3FMC3787 and 22 more
Model numbersHQD3FMC

Product

Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2727-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.