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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71907

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 27, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Transonic Systems Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.

Z-2720-2015
Recall number
Z-2720-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 4 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQC2FMC1801, HQC2FMC 1802, HQC2FMC1805, HQC2FMC1806

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 2 of 10

Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.

Z-2721-2015
Recall number
Z-2721-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 36 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 3 of 10

Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.

Z-2722-2015
Recall number
Z-2722-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Number: HQC6FMV2239

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 4 of 10

Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.

Z-2723-2015
Recall number
Z-2723-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 5 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 5 of 10

Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.

Z-2724-2015
Recall number
Z-2724-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 6 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQC2MP2763, HQC2MP2764, HQC2MP2769, HQC2MP2771, HQC2MP2772, HQC2MP2773

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 6 of 10

Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.

Z-2725-2015
Recall number
Z-2725-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 6 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQC3MP4665, HQC3MP4666, HQC3MP4667, HQC3MP4668, HQC3MP4669, HQC3MP4670

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 7 of 10

Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.

Z-2726-2015
Recall number
Z-2726-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 8 units, foreign: 11 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQD2FMC2797, HQD2FMC2873, HQD2FMC2874, HQD2FMC2875, HQD2FMC2876, HQD2FMC2877, HQD2FMC2878, HQD2FMC2879, HQD2FMC2880, HQD2FMC2881, HQD2FMC2882, HQD2FMC2883, HQD2FMC2884, HQD2FMC2885, HQD2FMC2886, HQD2FMC2888, HQD2FMC2889, HQD2FMC2890, HQD2FMC2908

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 8 of 10

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

Z-2727-2015
Recall number
Z-2727-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 35 units, Foreign: 12 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQD3FMC3763, HQD3FMC3764, HQD3FMC3765, HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770, HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775, HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780, HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785, HQD3FMC3786, HQD3FMC3787, HQD3FMC3788, HQD3FMC3789, HQD3FMC3790, HQD3FMC3791, HQD3FMC3792, HQD3FMC3793, HQD3FMC3794, HQD3FMC3795, HQD3FMC3796, HQD3FMC3797, HQD3FMC3798, HQD3FMC3799, HQD3FMC3800, HQD3FMC3801, HQD3FMC3802, HQD3FMC3803, HQD3FMC3804, HQD3FMC3805, HQD3FMC3806, HQD3FMC3807, HQD3FMC3814, HQD3FMC3815

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 9 of 10

Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.

Z-2728-2015
Recall number
Z-2728-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 15 units, Foreign: 2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

device · product 10 of 10

Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.

Z-2729-2015
Recall number
Z-2729-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Transonic Systems Inc
Quantity
Domestic: 2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: HQD6FMV2469, HQD6FMV2470

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.