{
  "companyId": "54354",
  "slug": "datex-ohmeda-inc-54354",
  "name": "Datex-Ohmeda, Inc.",
  "clearances": {
    "total": 103,
    "last12Months": 1,
    "first": "1998-11-06",
    "latest": "2025-10-22"
  },
  "medianReviewDays": 84,
  "productCodeCount": 21,
  "recalls": {
    "total": 56,
    "openLast12Months": 3,
    "recent": [
      {
        "resNumber": "Z-2357-2026",
        "productCode": "BTM",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-08",
        "reason": "Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient."
      },
      {
        "resNumber": "Z-2358-2026",
        "productCode": "FMT",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-08",
        "reason": "Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient."
      },
      {
        "resNumber": "Z-2359-2026",
        "productCode": "FMT",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-08",
        "reason": "Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient."
      },
      {
        "resNumber": "Z-0047-2025",
        "productCode": "FMZ",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2024-09-03",
        "reason": "GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose."
      },
      {
        "resNumber": "Z-0048-2025",
        "productCode": "FMZ",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2024-09-03",
        "reason": "GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose."
      }
    ]
  },
  "registration": {
    "sites": 3,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "BSZ",
      "deviceName": "Gas-Machine, Anesthesia",
      "clearances": 25,
      "latest": "2023-03-28",
      "medianReviewDays": 70
    },
    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
      "clearances": 15,
      "latest": "2005-02-18",
      "medianReviewDays": 66
    },
    {
      "code": "CBK",
      "deviceName": "Ventilator, Continuous, Facility Use",
      "clearances": 14,
      "latest": "2021-11-04",
      "medianReviewDays": 104
    },
    {
      "code": "MSX",
      "deviceName": "System, Network And Communication, Physiological Monitors",
      "clearances": 9,
      "latest": "2004-10-15",
      "medianReviewDays": 43
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 7,
      "latest": "2002-10-08",
      "medianReviewDays": 28
    },
    {
      "code": "CAD",
      "deviceName": "Vaporizer, Anesthesia, Non-Heated",
      "clearances": 6,
      "latest": "2018-01-04",
      "medianReviewDays": 72
    },
    {
      "code": "CAH",
      "deviceName": "Filter, Bacterial, Breathing-Circuit",
      "clearances": 5,
      "latest": "2005-03-01",
      "medianReviewDays": 89
    },
    {
      "code": "CCK",
      "deviceName": "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase",
      "clearances": 3,
      "latest": "2003-04-23",
      "medianReviewDays": 138
    },
    {
      "code": "FMZ",
      "deviceName": "Incubator, Neonatal",
      "clearances": 3,
      "latest": "2025-10-22",
      "medianReviewDays": 114
    },
    {
      "code": "MLD",
      "deviceName": "Monitor, St Segment With Alarm",
      "clearances": 3,
      "latest": "2002-11-14",
      "medianReviewDays": 87
    },
    {
      "code": "KNT",
      "deviceName": "Tubes, Gastrointestinal (And Accessories)",
      "clearances": 2,
      "latest": "1999-12-15",
      "medianReviewDays": 57
    },
    {
      "code": "OLW",
      "deviceName": "Index-Generating Electroencephalograph Software",
      "clearances": 2,
      "latest": "2003-01-13",
      "medianReviewDays": 90
    },
    {
      "code": "DPZ",
      "deviceName": "Oximeter, Ear",
      "clearances": 1,
      "latest": "2004-09-02",
      "medianReviewDays": 155
    },
    {
      "code": "DSA",
      "deviceName": "Cable, Transducer And Electrode, Patient, (Including Connector)",
      "clearances": 1,
      "latest": "2005-02-22",
      "medianReviewDays": 57
    },
    {
      "code": "DSI",
      "deviceName": "Detector And Alarm, Arrhythmia",
      "clearances": 1,
      "latest": "2002-07-24",
      "medianReviewDays": 84
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 1,
      "latest": "2003-06-06",
      "medianReviewDays": 29
    },
    {
      "code": "FMT",
      "deviceName": "Warmer, Infant Radiant",
      "clearances": 1,
      "latest": "2022-03-02",
      "medianReviewDays": 114
    },
    {
      "code": "HGM",
      "deviceName": "System, Monitoring, Perinatal",
      "clearances": 1,
      "latest": "2023-12-08",
      "medianReviewDays": 158
    },
    {
      "code": "MRN",
      "deviceName": "Apparatus, Nitric Oxide Delivery",
      "clearances": 1,
      "latest": "2000-02-10",
      "medianReviewDays": 27
    },
    {
      "code": "NLF",
      "deviceName": "Oximeter, Reprocessed",
      "clearances": 1,
      "latest": "2005-06-29",
      "medianReviewDays": 253
    },
    {
      "code": "OLT",
      "deviceName": "Non-Normalizing Quantitative Electroencephalograph Software",
      "clearances": 1,
      "latest": "2000-06-16",
      "medianReviewDays": 88
    }
  ],
  "productCodesShown": 21,
  "productCodesTotal": "21",
  "recentClearances": [
    {
      "kNumber": "K251663",
      "deviceName": "Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)",
      "productCode": "FMZ",
      "decisionDate": "2025-10-22",
      "reviewDays": 145
    },
    {
      "kNumber": "K231964",
      "deviceName": "Novii+ Wireless Patch System",
      "productCode": "HGM",
      "decisionDate": "2023-12-08",
      "reviewDays": 158
    },
    {
      "kNumber": "K213867",
      "deviceName": "Carestation 750/750c",
      "productCode": "BSZ",
      "decisionDate": "2023-03-28",
      "reviewDays": 473
    },
    {
      "kNumber": "K213553",
      "deviceName": "Giraffe Incubator Carestation CS1",
      "productCode": "FMZ",
      "decisionDate": "2022-03-02",
      "reviewDays": 114
    },
    {
      "kNumber": "K213551",
      "deviceName": "Giraffe Omnibed Carestation CS1",
      "productCode": "FMT",
      "decisionDate": "2022-03-02",
      "reviewDays": 114
    },
    {
      "kNumber": "K210384",
      "deviceName": "CARESCAPE R860",
      "productCode": "CBK",
      "decisionDate": "2021-11-04",
      "reviewDays": 268
    },
    {
      "kNumber": "K172702",
      "deviceName": "Tec 820, Tec 850",
      "productCode": "CAD",
      "decisionDate": "2018-01-04",
      "reviewDays": 119
    },
    {
      "kNumber": "K172045",
      "deviceName": "Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2",
      "productCode": "BSZ",
      "decisionDate": "2017-11-03",
      "reviewDays": 120
    },
    {
      "kNumber": "K170872",
      "deviceName": "Aisys CS2",
      "productCode": "BSZ",
      "decisionDate": "2017-08-15",
      "reviewDays": 145
    },
    {
      "kNumber": "K151570",
      "deviceName": "Carestation 620/650/650C",
      "productCode": "BSZ",
      "decisionDate": "2016-01-21",
      "reviewDays": 225
    }
  ],
  "nameVariants": {
    "total": "15",
    "shown": [
      {
        "name": "DATEX--OHMEDA, INC.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "DATEX--OHMEDA, INC.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datex - Ohmeda, Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datex Ohmeda",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Datex Ohmeda, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Datex Ohmeda, Inc.  dba GE Healthcare",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datex-Ohmeda",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datex-Ohmeda",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Datex-Ohmeda%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Datex-Ohmeda%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.044Z"
}