{
  "code": "BSZ",
  "deviceName": "Gas-Machine, Anesthesia",
  "deviceClass": "II",
  "regulationNumber": "868.5160",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 189,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 21357,
    "last12Months": 5788
  },
  "reviewDays": {
    "median": 111,
    "sampleSize": 189
  },
  "recalls": {
    "total": 173,
    "recent": [
      {
        "resNumber": "Z-2860-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Maquet Critical Care AB",
        "firmAsPublished": "Maquet Critical Care AB",
        "reason": "Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.",
        "initiated": "2026-06-24"
      },
      {
        "resNumber": "Z-2207-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Draeger, Inc.",
        "firmAsPublished": "Draeger, Inc.",
        "reason": "The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.",
        "initiated": "2026-05-07"
      },
      {
        "resNumber": "Z-2208-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Draeger, Inc.",
        "firmAsPublished": "Draeger, Inc.",
        "reason": "The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.",
        "initiated": "2026-05-07"
      },
      {
        "resNumber": "Z-0913-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "GE Medical Systems China Co., Ltd.",
        "firmAsPublished": "GE Medical Systems China Co., Ltd.",
        "reason": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.  \nAnesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur.   Following the reboot, the system will not return to the previous ventilation settings.",
        "initiated": "2025-11-14"
      },
      {
        "resNumber": "Z-0914-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "GE Medical Systems China Co., Ltd.",
        "firmAsPublished": "GE Medical Systems China Co., Ltd.",
        "reason": "Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.  \nAnesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over  to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, \nmanual ventilation, and volatile agent delivery may occur.   Following the reboot, the system will not return to the previous ventilation settings.",
        "initiated": "2025-11-14"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253330",
      "deviceName": "A5 Anesthesia System (A5); A7 Anesthesia System (A7)",
      "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "decisionDate": "2026-06-25",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K252746",
      "deviceName": "Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)",
      "applicant": "Drägerwerk AG Co. Kgaa",
      "company": "Drägerwerk AG Co. Kgaa",
      "decisionDate": "2026-05-21",
      "dateReceived": "2025-08-29"
    },
    {
      "kNumber": "K251352",
      "deviceName": "Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)",
      "applicant": "Codonics.Incorporated",
      "company": "Codonics.Incorporated",
      "decisionDate": "2025-07-11",
      "dateReceived": "2025-04-30"
    },
    {
      "kNumber": "K230931",
      "deviceName": "Atlan",
      "applicant": "Drägerwerk AG Co. Kgaa",
      "company": "Drägerwerk AG Co. Kgaa",
      "decisionDate": "2023-07-23",
      "dateReceived": "2023-04-03"
    },
    {
      "kNumber": "K213867",
      "deviceName": "Carestation 750/750c",
      "applicant": "Datex-Ohmeda, Inc.",
      "company": "Datex-Ohmeda, Inc.",
      "decisionDate": "2023-03-28",
      "dateReceived": "2021-12-10"
    },
    {
      "kNumber": "K201957",
      "deviceName": "A8, A9 Anesthesia System",
      "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "decisionDate": "2021-03-26",
      "dateReceived": "2020-07-14"
    },
    {
      "kNumber": "K191027",
      "deviceName": "Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System",
      "applicant": "Maquet Critical Care AB",
      "company": "Maquet Critical Care AB",
      "decisionDate": "2020-03-18",
      "dateReceived": "2019-04-18"
    },
    {
      "kNumber": "K171311",
      "deviceName": "A5 Anesthesia System",
      "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "decisionDate": "2018-01-12",
      "dateReceived": "2017-05-02"
    },
    {
      "kNumber": "K171292",
      "deviceName": "A7 Anesthesia System",
      "applicant": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "decisionDate": "2018-01-12",
      "dateReceived": "2017-05-02"
    },
    {
      "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",
      "applicant": "Datex-Ohmeda, Inc.",
      "company": "Datex-Ohmeda, Inc.",
      "decisionDate": "2017-11-03",
      "dateReceived": "2017-07-06"
    }
  ],
  "topApplicants": [
    {
      "name": "Draeger Medical, Inc.",
      "count": 33
    },
    {
      "name": "Datex-Ohmeda, Inc.",
      "count": 20
    },
    {
      "name": "Ohmeda Medical",
      "count": 17
    },
    {
      "name": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "count": 6
    },
    {
      "name": "GE Healthcare Finland Oy",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Draeger Medical, Inc.",
      "count": 35,
      "spellings": 2
    },
    {
      "name": "Datex-Ohmeda, Inc.",
      "count": 25,
      "spellings": 3
    },
    {
      "name": "Ohmeda Medical",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "GE Healthcare Finland Oy",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 346,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 361,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 436,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 372,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 413,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 448,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 373,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 567,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 504,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 479,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 470,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 477,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 488,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 497,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 494,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 554,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 570,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 481,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 546,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 496,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 515,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 383,
        "expectedLow": 423.8279665464374,
        "expectedHigh": 512.1786908186843,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 351,
        "expectedLow": 324.4375680027266,
        "expectedHigh": 446.38849417338434,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 465,
        "expectedLow": 341.88280880203865,
        "expectedHigh": 498.0846507265968,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 741,
        "expectedLow": 367.9655904522102,
        "expectedHigh": 528.5015619725546,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 1231,
        "expectedLow": 336.2254605397245,
        "expectedHigh": 668.4458935549062,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 991,
        "expectedLow": 255.31109421649916,
        "expectedHigh": 1240.9428225603704,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 1085,
        "expectedLow": 416.8029311259365,
        "expectedHigh": 2163.5373257272777,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 876,
        "expectedLow": 270.25859928015063,
        "expectedHigh": 1587.455468406614,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 716,
        "expectedLow": 265.64815485608585,
        "expectedHigh": 1653.8540445946978,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 874,
        "expectedLow": 205.0897608850586,
        "expectedHigh": 1557.4044041760496,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 659,
        "expectedLow": 193.7180304217447,
        "expectedHigh": 1390.3841150134094,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 799,
        "expectedLow": 187.02647625837352,
        "expectedHigh": 1479.990713390595,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 561,
        "expectedLow": 226.78631704153554,
        "expectedHigh": 1669.742518605476,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 791,
        "expectedLow": 98.27000246577767,
        "expectedHigh": 1310.1459779103118,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 770,
        "expectedLow": 181.00139472792713,
        "expectedHigh": 1422.8085165335197,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "BSZ (Gas-Machine, Anesthesia) has one finding. 5 recalls opened in the last 12 months and not yet terminated (Class I) (Z-2860-2026, Z-2207-2026, Z-2208-2026, Z-0913-2026, Z-0914-2026).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I)",
        "recordIds": [
          "Z-2860-2026",
          "Z-2207-2026",
          "Z-2208-2026",
          "Z-0913-2026",
          "Z-0914-2026"
        ],
        "severity": 85
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ABSZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABSZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABSZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ABSZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ABSZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ABSZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ABSZ"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.660Z"
}