Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 6 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 hazard involves a software defect causing incorrect readings, which is a functional failure but does not involve reported injuries or high-risk pathogens, fitting the Moderate criteria for minor errors or low-risk issues.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV. The recall involves two units with serial numbers HQD6FMV2469 and HQD6FMV2470. These devices are used to measure flow intra-operatively.
The recall is due to a software defect involving programming errors in the blood flow probes' EPROM. Transonic received complaints from users indicating that when the flow probe is connected to a flow meter, the meter incorrectly reads "Used Probe" or "Irrelevant Use Number."
The affected products were distributed worldwide, including the United States, Canada, Japan, Russia, and The Netherlands. Users should stop using the affected probes and contact Transonic Systems Inc for further instructions.
The recalled product
- Product
- Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
- Affected units
- 2
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 (2)
- Serial Numbers: HQD6FMV2469
- HQD6FMV2470
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