Transonic Flow Probe Recall 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, and the hazard involves a software defect causing incorrect readings rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for minor functional errors.
Plain-English summary
Transonic Systems Inc is recalling Transonic Flow Probes, 2 mm, Catalog Number HQD2FMC. The recall involves 8 units distributed domestically and 11 units distributed internationally to Canada, Japan, Russia, and The Netherlands.
The recall was initiated due to a software defect involving programming errors in the blood flow probes' EPROM. Users reported that when the flow probe is connected to a flow meter, the meter incorrectly displays "Used Probe" or "Irrelevant Use Number." These probes are used to measure flow intra-operatively.
Healthcare facilities and users should stop using the affected flow probes and contact Transonic Systems Inc for further instructions. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
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 (19)
- Serial Numbers: HQD2FMC2797
- HQD2FMC2873
- HQD2FMC2874
- HQD2FMC2875
- HQD2FMC2876
- HQD2FMC2877
- HQD2FMC2878
- HQD2FMC2879
- HQD2FMC2880
- HQD2FMC2881
- HQD2FMC2882
- HQD2FMC2883
- HQD2FMC2884
- HQD2FMC2885
- HQD2FMC2886
- HQD2FMC2888
- HQD2FMC2889
- HQD2FMC2890
- HQD2FMC2908
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
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