{
  "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": "41078",
      "product_res_number": "Z-0160-06",
      "event_date_initiated": "2005-08-05",
      "event_date_posted": "2005-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-10-24",
      "res_event_number": "32920",
      "product_code": "LBI",
      "product_description": "Ohmeda Giraffe SPOT PT Lite Phototherapy System",
      "code_info": "Serial numbers: HEBE50008    -    HEBE50019;  HEBF50001    -    HEBF50311;  HEBG50001    -    HEBG50751;  HEBH50001    -    HEBH50950;  HEBJ50000    -    HEBJ50432;  HEBG54001    -    HEBG54035;  HEBH54001    -    HEBH54999; HEBH55000    -    HEBH55041;  HEBJ55033    -    HEBJ55036;",
      "firm_fei_number": "1121732",
      "recalling_firm": "Datex Ohmeda, Inc.  dba GE Healthcare",
      "address_1": "8880 Gorman Rd",
      "city": "Laurel",
      "state": "MD",
      "postal_code": "20723-5800",
      "additional_info_contact": "Ann Lebar\n414-362-2703",
      "reason_for_recall": "Phototherapy medical device may lose its position and can cause a safety hazard to the patient.",
      "root_cause_description": "Other",
      "action": "The firm notified consignees by letter on 08/05/2005 and advised of field correction of the devices in 2 phases. The letter is lot specific and provides for an interim workaround and includes an adhesive sticker and instructions for tagging the device with a warning statement containing restriction for use : 'This phototherapy light should ONLY be used on patients in closed incubators.'  The letter further advises of firm''s plan to provide free, mandatory repair at a later date, pending hardware solution.",
      "product_quantity": "2701 devices",
      "distribution_pattern": "Product was distributed to medical facilities in the US and international subsidiaries and distributors.",
      "openfda": {
        "k_number": [
          "K854122",
          "K974830",
          "K011549",
          "K810953",
          "K934946",
          "K110550",
          "K160238",
          "K910571",
          "K902749",
          "K010495",
          "K071828",
          "K163526",
          "K120168",
          "K791114",
          "K200031",
          "K971256",
          "K834335",
          "K850181",
          "K072097",
          "K120820",
          "K882291",
          "K771025",
          "K160745",
          "K834430",
          "K760872",
          "K131196",
          "K892940",
          "K083179",
          "K830200",
          "K883779",
          "K901987",
          "K070180",
          "K884133",
          "K903445",
          "K172656",
          "K940996",
          "K142332",
          "K984589",
          "K190899",
          "K093618",
          "K103828",
          "K111547",
          "K022196",
          "K113206",
          "K931965",
          "K210289",
          "K040853",
          "K954611",
          "K090192",
          "K840454",
          "K103735",
          "K002414",
          "K160305",
          "K850599",
          "K182178",
          "K243372",
          "K813188",
          "K962612",
          "K802702",
          "K971601",
          "K873700",
          "K912908",
          "K051869",
          "K053568",
          "K103589",
          "K170585",
          "K251308",
          "K021531",
          "K832298",
          "K991627",
          "K894129"
        ],
        "registration_number": [
          "1000312377",
          "3002807523",
          "3012348048",
          "3000279201",
          "3014128880",
          "1000617661",
          "3014220748",
          "9612197",
          "1419937",
          "9617277",
          "3005934741",
          "3013424071",
          "3005652389",
          "1625392",
          "2510954",
          "3006179052",
          "1066270",
          "2133810",
          "1930027",
          "3013919653",
          "3042972073",
          "3007734888",
          "3036470679",
          "3010611950",
          "9611451",
          "2085602",
          "1000122810"
        ],
        "fei_number": [
          "1000312377",
          "3002807523",
          "3012348048",
          "3000203066",
          "3000279201",
          "3014128880",
          "1000617661",
          "3002807554",
          "3014220748",
          "1419937",
          "3005934741",
          "3013424071",
          "3004846435",
          "2510954",
          "3006179052",
          "1930027",
          "3013919653",
          "3042972073",
          "3007734888",
          "3000210616",
          "3036470679",
          "3010611950",
          "3000957797",
          "3002806988",
          "1000058335",
          "1000122810",
          "3003190524"
        ],
        "device_name": "Unit, Neonatal Phototherapy",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5700",
        "device_class": "2"
      }
    }
  ]
}