Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Transonic Systems Inc is recalling 6 units of the Transonic Flow Probe, 2 mm, Catalog Number HQC2MP. The recall is due to a software defect involving programming errors in the blood flow probes' EPROM.
The defect causes the flow meter to display 'Used Probe' or 'Irrelevant Use Number' when the probe is connected. Transonic received several complaints from users regarding these incorrect readings. The affected probes are used to measure flow intra-operatively.
The affected units were distributed worldwide, including the US, Canada, Japan, Russia, and The Netherlands. Users should stop using the affected probes and contact Transonic Systems Inc for instructions on return or replacement.
The recalled product
- Product
- Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- 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: HQC2MP2763
- HQC2MP2764
- HQC2MP2769
- HQC2MP2771
- HQC2MP2772
- HQC2MP2773
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.
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