Transonic Flow Probe Recalled Due to Software Defect in EPROM
Transonic Systems Inc is recalling a 6 mm Transonic Flow Probe due to a software defect causing incorrect meter readings.
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 readings, which is a functional failure but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Transonic Systems Inc is recalling one unit of the Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV. The product is used to measure flow intra-operatively. 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 unit has the serial number HQC6FMV2239.
The product was distributed worldwide, including the United States, Canada, Japan, Russia, and The Netherlands. Users should stop using the affected probe and contact Transonic Systems Inc for further instructions.
The recalled product
- Product
- Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
- Manufacturer
- Transonic Systems Inc
- Affected units
- 1
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 (1)
- Serial Number: HQC6FMV2239
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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