{
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    "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/",
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      "product_res_number": "Z-1280-2023",
      "event_date_initiated": "2022-12-19",
      "event_date_posted": "2023-03-22",
      "recall_status": "Open, Classified",
      "res_event_number": "91523",
      "product_code": "DPS",
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      "product_description": "Scan Monitor/ScanWatch, model number hwa09\n\nWearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)",
      "code_info": "UDI-DI 03700546706400\n\nSerial 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      "firm_fei_number": "3008820594",
      "recalling_firm": "Withings",
      "address_1": "37 Bis Rue Du General Leclerc",
      "city": "Issy les Moulineaux CEDEX",
      "country": "France",
      "additional_info_contact": "Customer Service\n888-2294116",
      "reason_for_recall": "A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.",
      "root_cause_description": "Software Design Change",
      "action": "Users were initially notified via push notifications in the companion app on December 19, 2022, which instructed users to update the app and activate the ECG feature under a physician.\n\nOn February 10, 2023, the firm followed up with customers via Medical Device Recall letters. Customers were instructed to ensure their Health Mate app is updated to iOS 5.13.0 or higher, and to ensure their device is synchronized with the Health Mate app. Customers should follow the instructions on their Health Mate app to activate their ECG feature.\n\nContact Information for questions:\nEmail: deals-support@withings.com\nPhone number: 1-888-229-4116 (Availability Mon - Fri, 08:00 - 22:00 EST, 13:00 - 03:00 GMT, 14:00 - 04:00 CET).",
      "product_quantity": "38,886 (US)",
      "distribution_pattern": "Nationwide distribution in the US. No foreign distribution.",
      "openfda": {
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