Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects 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. The hazard involves software errors leading to incorrect readings, which is a functional defect without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Transonic Systems Inc is recalling the Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC. The recall involves 15 units distributed domestically in the United States and 2 units distributed in Canada, Japan, Russia, and The Netherlands.
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 displays "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 affected serial numbers range from HQD4FMC3504 to HQD4FMC3520.
The recalled product
- Product
- Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- 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 (17)
- Serial Numbers: HQD4FMC3504
- HQD4FMC3505
- HQD4FMC3506
- HQD4FMC3507
- HQD4FMC3508
- HQD4FMC3509
- HQD4FMC3510
- HQD4FMC3511
- HQD4FMC3512
- HQD4FMC3513
- HQD4FMC3514
- HQD4FMC3515
- HQD4FMC3516
- HQD4FMC3517
- HQD4FMC3518
- HQD4FMC3519
- HQD4FMC3520
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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