{
  "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": {
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  "results": [
    {
      "cfres_id": "109204",
      "product_res_number": "Z-0447-2013",
      "event_date_initiated": "2012-05-09",
      "event_date_posted": "2012-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-01-27",
      "res_event_number": "61835",
      "product_code": "MXM",
      "pma_numbers": [
        "P040025"
      ],
      "product_description": "The product has the Catalogue/Part number 60010.\n\nOlympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants.  A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers.  The Cool-Cap provides 72 hours of monitored cooling. \n\nThe device is labeled in parts: \"***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***\"",
      "code_info": "1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1029; 1030; 1031; 1032; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1079; 1080; 1081; 1082; 1083; 1084; 1085; 1086; 1087; 1088; 1089; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1098; 1101; 1116; 1117; 1118; 1119; 1120; 1121; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1134; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7012; 7013; 7014; 7015; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7029; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7050; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7254; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7266; 7268; 7269; 7274; 7276; 7277; 7281; 7286; 7287; 7289; 7293; 7305; 7306; 7307; 7308; 7310; 7311; 7327; 7330; 7348; 7351; 7356; 7358; 7360; 7363; 7364; 7365; 7366; 7367; 7368; 7369; 7370; 7371; 7372; 7374; 7375; 7376; 7377; 7378; 7380; 7381; 7383; 7384; 7385; 7386; 7387; 7388; 7389; 7394; 7400; 7401; 7402; 7405; 7406; 7407; 7409; 7410; 7411; 7412; 7413; 7414; 7416; 7418; 7420; 7421; 7424; 7431; 7433; 7434; 7435; 7436; 7437; 7438; 7440; 7441; 7265; 7267; 7270; 7271; 7272; 7273; 7275; 7278; 7279; 7280; 7282; 7283; 7284; 7285; 7288; 7290; 7291; 7292; 7294; 7295; 7296; 7297; 7298; 7299; 7300; 7301; 7302; 7303; 7304; 7309; 7312; 7313; 7314; 7315; 7316; 7317; 7318; 7319; 7320; 7321; 7322; 7323; 7324; 7325; 7326; 7328; 7329; 7331; 7332; 7333; 7334; 7335; 7336; 7337; 7338; 7339; 7340; 7341; 7342; 7343; 7344; 7345; 7346; 7347; 7349; 7350; 7352; 7353; 7354; 7355; 7357; 7359; 7361; 7362; 7379; 7382; 7391; 7392; 7393; 7395; 7397; 7398; 7399; 7403; 7404; 7408; 7422; 7423; 7429; 7432.",
      "firm_fei_number": "3018859",
      "recalling_firm": "Natus Medical Incorporated",
      "address_1": "5900 1st Ave S",
      "city": "Seattle",
      "state": "WA",
      "postal_code": "98108-3248",
      "additional_info_contact": "Natus Technical Service\n888-496-2887",
      "reason_for_recall": "The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants.  The visible clock displayed at the upper right hand corner of the screen stops advancing.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm, Natus Medical Incorporated, sent its customers an \"URGENT: MEDICAL DEVICE\" letter dated May 16, 2012 with an attached Field Safety Notice.  The letter describes the product, problem and actions taken.  Customers can call Natus Technical Service at 888-496-2887 for any questions about this recall.",
      "product_quantity": "324 units",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of:  AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, and countries of:  Argentina, Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Ecuador, Egypt, Germany, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Kuwait, Latvia, Malaysia, Mexico, Morocco, Panama, Puerto Rico, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.",
      "openfda": {
        "pma_number": [
          "P040025"
        ],
        "device_name": "Cap, Cooling (Infants)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}