Emano Flow with software version v2: recall status

Notice names this product. Emano Metrics’s Emano Flow with software version v2 is named in FDA Class II recall Z-2777-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Identifying details: Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress. Units affected: 685. Status: Ongoing.