Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.
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, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional software error causing incorrect readings, which fits the criteria for a moderate severity recall without reported adverse health consequences.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC. The recall involves 35 domestic units and 12 foreign units distributed in the United States, Canada, Japan, Russia, and The Netherlands.
The recall is 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 reads "Used Probe" or "Irrelevant Use Number."
Healthcare facilities 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 HQD3FMC -- 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 (20)
- Serial Numbers: HQD3FMC3763
- HQD3FMC3764
- HQD3FMC3765
- HQD3FMC3766
- HQD3FMC3767
- HQD3FMC3768
- HQD3FMC3769
- HQD3FMC3770
- HQD3FMC3771
- HQD3FMC3772
- HQD3FMC3773
- HQD3FMC3774
- HQD3FMC3775
- HQD3FMC3776
- HQD3FMC3777
- HQD3FMC3778
- HQD3FMC3779
- HQD3FMC3780
- HQD3FMC3781
- HQD3FMC3782
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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- 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
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