{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "221511",
      "product_res_number": "Z-2959-2026",
      "event_date_initiated": "2026-07-08",
      "event_date_posted": "2026-08-14",
      "recall_status": "Open, Classified",
      "res_event_number": "99410",
      "product_code": "ILQ",
      "product_description": "TD Navio Midi Speech Generating Device\nModel/Catalog Number: 1000798",
      "code_info": "UDI-DI 073400747602056\nSerial Numbers TDNM1-240628000004 through\nTDNM1-260617070001. \n\nCorrected/future production is differentiated by new serialization from\nTDNM1-260617070001 onward (production batch 20260615, improved design).",
      "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",
      "additional_info_contact": "Bob Lizewski\n+1-800-3441778 Ext. 1",
      "reason_for_recall": "Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.",
      "root_cause_description": "Device Design",
      "action": "On July 8, 2026, the firm notified customers by emailing letters titled \"URGENT: MEDICAL DEVICE RECALL NOTICE.\"\n\nCustomers were informed that Tobii Dynavox would provide a repair authorization number (RA#), prepaid shipping label, inspection, repair, and return shipping for the affected device. The repair will include modifications intended to improve battery stability within the device.\n\nCustomers were provided with ways to contact the company to obtain a repair authorization number.\n\nCustomers were informed that it is safe to continue using the device as intended while waiting for the repair, as long as there are no signs of overheating, swelling, unusual odor, smoke, deformation, or battery abnormality. If any of these conditions are observed, discontinue use immediately and contact Tobbi Dynavox.",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "System, Communication, Powered",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3710",
        "device_class": "2"
      }
    }
  ]
}