The Recall Desk
ModerateFDA (Devices)·Z-2728-2015·Announced 2015-09-09

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.

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 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
Category
Medical Device — Surgical Instruments
Hazard

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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Same hazard · software defect

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