{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "68118",
      "product_res_number": "Z-1051-2008",
      "event_date_initiated": "2008-01-31",
      "event_date_posted": "2008-03-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-05-08",
      "res_event_number": "46742",
      "product_code": "FMZ",
      "k_numbers": [
        "K941106"
      ],
      "product_description": "Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505.  Draeger Medical, Inc., Telford, PA  18969",
      "code_info": "Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.",
      "firm_fei_number": "2517967",
      "recalling_firm": "Draeger Medical, Inc.",
      "address_1": "3135 Quarry Rd",
      "city": "Telford",
      "state": "PA",
      "postal_code": "18969-1042",
      "additional_info_contact": "Kathy Anderson\n215-721-5400",
      "reason_for_recall": "Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm notified consignees on 2/1/08, by an Important Safety Notice.  The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board.  A Service Representative will be in contact to schedule a service visit.  For questions concerning this recall please contact 215-660-2418 or Anbu.arasu@draeger.com.",
      "product_quantity": "18 units",
      "distribution_pattern": "Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.",
      "openfda": {
        "k_number": [
          "K001242",
          "K072512",
          "K922618",
          "K870223",
          "K840526",
          "K040910",
          "K821896",
          "K993407",
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          "K962806",
          "K895782",
          "K914487",
          "K832418",
          "K102279",
          "K102226"
        ],
        "registration_number": [
          "3007734888",
          "9613793",
          "3008729547",
          "3036470679",
          "3014220748",
          "3009077524",
          "1034876",
          "9710602",
          "3006179052",
          "3005934741",
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          "9611500",
          "3049808762",
          "3030089838",
          "3030733800",
          "2510954",
          "1000122786",
          "3005652389",
          "1066270",
          "1226711",
          "1054241",
          "3021559257",
          "1055236",
          "1054713",
          "3012348048"
        ],
        "fei_number": [
          "1000112877",
          "3007734888",
          "3008729547",
          "3006469671",
          "3001104093",
          "3036470679",
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          "1000114111",
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          "3004846435",
          "3012348048",
          "3000957797"
        ],
        "device_name": "Incubator, Neonatal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5400",
        "device_class": "2"
      }
    }
  ]
}