Emano Metrics, Inc.: Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Softw

Company / brand

Emano Metrics, Inc.

Product

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed digitally via mobile application.

Reason / hazard

Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

Classification

Class II

Status

Ongoing

Distribution / sold at

U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.

Recall initiated

2026-05-29

Code info

Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress

Product quantity

685

Voluntary mandated

Voluntary: Firm initiated

City

Eugene

State

OR

Country

United States

Event id

99241

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