{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221128",
      "product_res_number": "Z-2777-2026",
      "event_date_initiated": "2026-05-29",
      "event_date_posted": "2026-07-22",
      "recall_status": "Open, Classified",
      "res_event_number": "99241",
      "product_code": "EXY",
      "product_description": "Emano Flow with software version v2.0.0\nGS1 GTIN code: 199874903484\n\nEmano 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.",
      "code_info": "Software Version - 2.0.0\nGS1 GTIN code: 199874903484\nUDI code: GUDID registration is in progress",
      "firm_fei_number": "3021350028",
      "recalling_firm": "Emano Metrics, Inc.",
      "address_1": "132 E Broadway Ste 101 132 E Broadway",
      "address_2": "Ste 101",
      "city": "Eugene",
      "state": "OR",
      "postal_code": "97401-3150",
      "additional_info_contact": "Edouard Hay\n541-434-4414",
      "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.",
      "root_cause_description": "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.\n\nCustomer were also informed that, the correction (updated software) was deployed on May 29, 2026.\n\nAn updated customer notice was emailed on 06/23/2026.\n\nInstructions provided to Customer included:\n1. Review the corrected results for patients with Emano Flow data from the affected period, prioritizing cases where the data informed a clinical decision.\n2. 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.\n3. Please reply to this email to confirm receipt of this notice.",
      "product_quantity": "685",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.",
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        "registration_number": [
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          "3017845305",
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          "3020978007",
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        ],
        "device_name": "Uroflowmeter",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1800",
        "device_class": "2"
      }
    }
  ]
}