Transonic Flow Probe Recalled Due to Software Defect
Transonic Systems Inc is recalling 36 Transonic Flow Probes due to programming errors that cause 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, and the defect results in incorrect readings rather than direct physical injury, fitting the criteria for a moderate severity recall.
Plain-English summary
Transonic Systems Inc is recalling 36 units of the Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC. 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 units were distributed worldwide, including in the United States, Canada, Japan, Russia, and The Netherlands.
Users should stop using the affected probes and contact Transonic Systems Inc for instructions on how to proceed.
The recalled product
- Product
- Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
- Affected units
- 36
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: HQC3FMC2501
- HQC3FMC2502
- HQC3FMC2503
- HQC3FMC2504
- HQC3FMC2505
- HQC3FMC2506
- HQC3FMC2507
- HQC3FMC2508
- HQC3FMC2509
- HQC3FMC2510
- HQC3FMC2511
- HQC3FMC2512
- HQC3FMC2513
- HQC3FMC2514
- HQC3FMC2515
- HQC3FMC2516
- HQC3FMC2517
- HQC3FMC2518
- HQC3FMC2519
- HQC3FMC2520
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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