Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmet

FDA device recall Z-2777-2026 · posted 2026-07-22 · Open, Classified

Recall details

Recalling firm

Emano Metrics, Inc.

Reason for recall

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.

Action taken

On 06/10/2026, a "Medical Device Correction" Letter was emailed to customers informing them that it would found that Emano Flow software versions v2.2.0-v2.3.4 processed audio at a sample rate that did not match the sample rate expected by the flow prediction algorithms (model version v2.0.0), affecting results generated between 03/22/2026 to 05/29/2026. Customer were also informed that, the correction (updated software) was deployed on May 29, 2026. An updated customer notice was emailed on 06/23/2026. Instructions provided to Customer included: 1. Review the corrected results for patients with Emano Flow data from the affected period, prioritizing cases where the data informed a clinical decision. 2. If customers have previously downloaded patient reports generated between 03/22/2026 and 05/29/2026, replace them with the corrected versions available in the Emano Flow clinic portal. A spreadsheet with secure links to all corrected reports is attached. 3. Please reply to this email to confirm receipt of this notice.

Root cause

Software Design Change

Status

Open, Classified

Product code

EXY

Quantity affected

685

Distribution

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

Date initiated

2026-05-29

Date posted

2026-07-22

Location

Eugene, OR