FDA Medical Device Recalls (openFDA)
Emano Metrics, Inc.: 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.
- Recall number
- Z-2777-2026
- Recalling firm
- 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.
- Status
- Open, Classified
- Initiated
- 2026-05-29
- Posted
- 2026-07-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software Design Change
- Action
- 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.
- Quantity
- 685
- Distribution
- U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
- Lot, serial or model codes
- Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EXY
- Firm FEI
- 3021350028
- Firm city
- Eugene
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28