Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 8 mm Flow Probes due to a software defect that causes flow meters to display incorrect error 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 hazard involves a software defect causing incorrect error messages, which is a functional issue without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV. The recall involves 5 units distributed domestically and internationally to Canada, Japan, Russia, and The Netherlands. The affected serial numbers are HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, and HQC8FMV2146.
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 product is used to measure flow intra-operatively.
Users should stop using the affected flow probes and contact Transonic Systems Inc for further instructions.
The recalled product
- Product
- Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
- Hazard
- Affected units
- 5
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 (5)
- Serial Numbers: HQC8FMV2142
- HQC8FMV2143
- HQC8FMV2144
- HQC8FMV2145
- HQC8FMV2146
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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