Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 3 mm Flow Probes due to a software defect that causes flow meters to display incorrect status messages.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 defect causes incorrect meter readings, which is a functional failure but does not involve reported injuries, deaths, or high-risk pathogens, fitting the criteria for a moderate severity recall.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Flow Probe, 3 mm, Catalog Number HQC3MP. The recall involves 6 units distributed domestically in the United States and internationally in Canada, Japan, Russia, and The Netherlands. The affected serial numbers are HQC3MP4665, HQC3MP4666, HQC3MP4667, HQC3MP4668, HQC3MP4669, and HQC3MP4670.
The recall is due to a software defect involving programming errors in the blood flow probes' EPROM. Users have reported that when the flow probe is connected to a flow meter, the meter incorrectly reads "Used Probe" or "Irrelevant Use Number." The product is used to measure flow intra-operatively.
Healthcare providers and users should stop using the affected probes and contact Transonic Systems Inc for further instructions.
The recalled product
- Product
- Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
- Affected units
- 6
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 (6)
- Serial Numbers: HQC3MP4665
- HQC3MP4666
- HQC3MP4667
- HQC3MP4668
- HQC3MP4669
- HQC3MP4670
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 in EPROM
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
FDA (Devices) · 2015-09-09
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighTransonic Hemodialysis Monitor Recall Due to Inaccurate Flow Measurements
FDA (Devices) · 2015-03-25
- HighTerumo Flowmeter Module Recalled for Inaccurate Flow Readings
FDA (Devices) · 2018-05-02
- HighICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
FDA (Devices) · 2014-08-13
- HighTransonic AV Loop Kit Recalled for Blood Leakage Complaints
FDA (Devices) · 2013-04-24
- ModerateWalkMed Recalls Triton FP Infusion Pumps Due to Labeling Error
FDA (Devices) · 2014-03-12
- HighICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak
FDA (Devices) · 2014-08-13