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.
Publicado el 29 de julio de 2026 · Inicio del retiro: 29 de mayo de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Emano Metrics, Inc.
- Distribuidor
- U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
- Lote
- Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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