Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a functional defect causing incorrect readings but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC. The recall is due to a software defect involving programming errors in the blood flow probes' EPROM. This defect causes the connected flow meter to display "Used Probe" or "Irrelevant Use Number" when the probe is connected.
The affected units are used to measure flow intra-operatively. Four domestic units are included in this recall. The products were distributed worldwide, including the United States, Canada, Japan, Russia, and The Netherlands. The specific serial numbers affected are HQC2FMC1801, HQC2FMC 1802, HQC2FMC1805, and HQC2FMC1806.
Users should stop using the affected probes and contact Transonic Systems Inc for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Serial Numbers: HQC2FMC1801
- HQC2FMC 1802
- HQC2FMC1805
- HQC2FMC1806
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Transonic Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Transonic Systems Inc
See all →- HighTransonic ADT1018 Hemodialysis Tubing Recalled Due to Sterility Concerns
FDA (Devices) · 2018-05-16
- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect in EPROM
FDA (Devices) · 2015-09-09
- ModerateTransonic Flow Probe Recalled Due to Software Defect
FDA (Devices) · 2015-09-09
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25