{
  "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": "2026-09-20",
    "results": {
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  "results": [
    {
      "cfres_id": "199104",
      "product_res_number": "Z-1399-2023",
      "event_date_initiated": "2023-02-24",
      "event_date_posted": "2023-04-18",
      "recall_status": "Open, Classified",
      "res_event_number": "91884",
      "product_code": "ILQ",
      "product_description": "Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for  ambulatory people with disabilities.\nCatalog #:  750567",
      "code_info": "UDI: 7340074601714\nSerial Numbers: TD110-211005000001 through TD110-220927004400",
      "firm_fei_number": "3004959902",
      "recalling_firm": "Tobii Dynavox Llc",
      "address_1": "2100 Wharton St Ste Ste 400 2100 Wharton St",
      "address_2": "Ste Ste 400",
      "city": "Pittsburgh",
      "state": "PA",
      "postal_code": "15203-1691",
      "reason_for_recall": "Problem maintaining the stable placement of the battery\nmay come loose from the housing and become damaged.",
      "root_cause_description": "Device Design",
      "action": "Tobii Dynavox issued Urgent Medical Device Recall Letter on 2/24/23. Letter states reason for recall, health risk and action to take: \nTobii Dynavox will, at its full expense, provide you with a repair authorization number (RA#) and a shipping label to have the device inspected and repaired by adding more stability to the battery s position within the device.\nWhat should you do? There are numerous ways to contact the company to obtain a RA#:\nOnline: https://us.tobiidynavox.com/pages/recall\nToll Free: 800-344-1778, press 1, then press 2 (for the TD I-110 team)\nBy Email: Recall@tobiidynavox.com\nWe will provide you with your RA# and shipping labels via email, or by phone and mail where email is not possible. We will expedite all recalled battery repairs and return shipping to you, so you are without your device for as short a time as possible.\nYou should obtain a RA# for the free repair to ensure that your device continues working as expected. You can continue to use your device and charge it as usual until you receive your RA# and shipping label.\nAs with any Lithium-Ion battery, you should never puncture or vent a battery pack. You should not attempt to change the battery yourself or to remove the battery. This should only be done by a trained service technician. The device should not be stored in extremely hot conditions, as stated in the product manual, over 158F or 70C.\nPlease use any of the methods above to tell us if your device is no longer in service. We will continue to contact all customers regarding this recall to be sure all customers are notified.",
      "product_quantity": "3924 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, \nBelgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland\nIreland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, \nUnited Arab Emirates, United Kingdom.",
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        "registration_number": [
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          "1000123978",
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        ],
        "device_name": "System, Communication, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3710",
        "device_class": "2"
      }
    }
  ]
}