{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "103617",
      "product_res_number": "Z-0340-2012",
      "event_date_initiated": "2011-08-23",
      "event_date_posted": "2011-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-09-09",
      "res_event_number": "59767",
      "product_code": "FMZ",
      "k_numbers": [
        "K102226"
      ],
      "product_description": "Infa Warmer i (Atom Infant Warmer Model 103)\n\nAtom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033\n\nUsage: A warmer for infants.",
      "code_info": "All lots on the market.  model 103",
      "firm_fei_number": "3005652389",
      "recalling_firm": "Atom Medical Corporation",
      "address_1": "3-18-15 Hongo",
      "city": "Bunkyo-Ku",
      "country": "Japan",
      "reason_for_recall": "The caster with lock on the radiant-warming open type incubator may become loose or break.",
      "root_cause_description": "Device Design",
      "action": "The firm, Atom Medical, sent an \"Urgent: Field Safety Notice\" letter dated August 18, 2011, to its customers. The letter described the product, problem and actions to be taken.  The customers were instructed to immediately identify all devices in their inventory and quarantine them until the rework is complete; identify any customers to whom they have further distributed the product; contact their customers at once and arrange a time in which the field service technician can perform the rework (the parts needed to complete the rework will be sent from Atom Medical's export department ); complete rework of all affected devices and document rework on the Distributor FSCA/Recall Response Form and return via Fax to: +81 3 3812-3199 or email to kira-utc@atomed.co.jp; t-sugino@atomed.co.jp or kenichi.shimada@atomed.co.jp (all forms should be completed and returned by January 31, 2012.) \n\nIf you have any questions, contact the Manager Quality Control  or Manager, Regulatory Affairs at email addresses above,  phone: +81-3-3815-3632 or fax +81-3-3812-3199.",
      "product_quantity": "133 units",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including state of: PA and countries of: Algeria, Austria, Australia, China, Egypt, Germany, Italy, Japan, Korea, Kuwait, Malaysia, Portugal, Russia, Saudi Arabia, Spain, Switzerland, Thailand, The Netherlands, and UAE.",
      "openfda": {
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          "K840526",
          "K943360",
          "K780472",
          "K003067",
          "K821896",
          "K021809",
          "K813239",
          "K822656",
          "K781876",
          "K871399",
          "K251663",
          "K031387",
          "K924297",
          "K920049",
          "K182977",
          "K993712",
          "K884086",
          "K960980",
          "K895550",
          "K912000",
          "K020547",
          "K901157",
          "K912909",
          "K251619",
          "K102710",
          "K801461",
          "K072512",
          "K924324",
          "K061856",
          "K040910",
          "K900752",
          "K152814",
          "K101778",
          "K040068",
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          "K213553",
          "K914864",
          "K061280",
          "K913291",
          "K954204",
          "K924170",
          "K182859"
        ],
        "device_name": "Incubator, Neonatal",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5400",
        "device_class": "2",
        "registration_number": [
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}