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.
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 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
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