{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "205499",
      "product_res_number": "Z-0810-2024",
      "event_date_initiated": "2023-12-29",
      "event_date_posted": "2024-01-25",
      "recall_status": "Open, Classified",
      "res_event_number": "93788",
      "product_code": "LNI",
      "k_numbers": [
        "K193215"
      ],
      "product_description": "Ingenia Ambition X, Model No. 782109",
      "code_info": "Model No. 782109\nUDI-DI 00884838098350\nSerial Number 47785",
      "firm_fei_number": "3006648320",
      "recalling_firm": "Philips North America",
      "address_1": "222 Jacobs St",
      "city": "Cambridge",
      "state": "MA",
      "postal_code": "02141-2296",
      "additional_info_contact": "Customer Care Solution Center\n800-722-9377",
      "reason_for_recall": "An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On December 29, 2023, the firm notified affected customers with URGENT Medical Device Correction letters.\n\nThe firm stated there is no impact to patients or users. There is a potential risk of electrical shock for service personnel.\n\nCustomers may continue to use MR systems in accordance with the intended use. Circulate this notice to all users of this device so that they are aware of the issue, and post the letter in the technical room until the electrical shock warning label is updated.\n\nA Philips representative will contact you to schedule a time for a Field Service Engineer to verify the electrical shock warning label and apply the correct label if applicable.\n\nIf you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).",
      "product_quantity": "7 US; 16 ROW total",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.",
      "openfda": {
        "k_number": [
          "K071506",
          "K003575",
          "K984167",
          "K962627",
          "K930265",
          "K010129",
          "K011604",
          "K991568",
          "K093044",
          "K970005"
        ],
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        "fei_number": [
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          "3015329423",
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          "3023003446",
          "3033527281",
          "3007350713",
          "1000571342",
          "3005877899",
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        ],
        "device_name": "System, Nuclear Magnetic Resonance Spectroscopic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1000",
        "device_class": "2"
      }
    }
  ]
}