{
  "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": "183737",
      "product_res_number": "Z-0131-2021",
      "event_date_initiated": "2020-09-08",
      "event_date_created": "2020-10-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-28",
      "res_event_number": "86452",
      "product_code": "OUO",
      "k_numbers": [
        "K163619"
      ],
      "product_description": "Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.",
      "code_info": "Model: 5726207-8 and 5741000-28",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "Stephanie Cass\n262-312-7277",
      "reason_for_recall": "Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.",
      "root_cause_description": "Process change control",
      "action": "On 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions:\nYou can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation.\n\nGE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA.\n\nThe countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.",
      "openfda": {
        "k_number": [
          "K200213",
          "K183014",
          "K234154",
          "K172531",
          "K192672",
          "K142098",
          "K253963",
          "K103429",
          "K133226",
          "K163234",
          "K253023",
          "K213709",
          "K222540",
          "K103483",
          "K163619"
        ],
        "registration_number": [
          "2247992",
          "3015329423",
          "3011015597",
          "3011950073",
          "3002808157",
          "3015232217",
          "1529041",
          "3004754211",
          "3005326970",
          "2183553",
          "3010949642"
        ],
        "fei_number": [
          "3015329423",
          "3011015597",
          "3011950073",
          "3002808157",
          "3015232217",
          "1000208827",
          "3004754211",
          "3005326970",
          "3005214683",
          "2183553",
          "3010949642"
        ],
        "device_name": "Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1200",
        "device_class": "2"
      }
    }
  ]
}