{
  "companyId": "57526",
  "slug": "respironics-inc-57526",
  "name": "Respironics, Inc.",
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    "last12Months": 0,
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    "latest": "2024-12-30"
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    "openLast12Months": 0,
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        "resNumber": "Z-2024-2012",
        "productCode": "CBK",
        "status": "Terminated",
        "recallClass": "Class I",
        "initiated": "2012-04-27",
        "reason": "The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply."
      },
      {
        "resNumber": "Z-0296-2012",
        "productCode": "CBK",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2011-10-11",
        "reason": "Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process.  If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure.  This may impact therapy."
      },
      {
        "resNumber": "Z-1896-2010",
        "productCode": "CBK",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2010-06-10",
        "reason": "It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event."
      },
      {
        "resNumber": "Z-1411-2009",
        "productCode": "FLS",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2009-04-23",
        "reason": "Audible alarm failure."
      },
      {
        "resNumber": "Z-1260-2009",
        "productCode": "BZD",
        "status": "Terminated",
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        "initiated": "2009-02-05",
        "reason": "Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA."
      }
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    "countries": [
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    {
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    {
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      "code": "BTM",
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    {
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    {
      "code": "CAW",
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    {
      "code": "BTT",
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      "code": "BYJ",
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    {
      "code": "CBH",
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    {
      "code": "GWK",
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    {
      "code": "OLZ",
      "deviceName": "Automatic Event Detection Software For Polysomnograph With Electroencephalograph",
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      "latest": "2020-10-29",
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    {
      "code": "BYT",
      "deviceName": "Ventilator, External Body, Negative Pressure, Adult (Cuirass)",
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    },
    {
      "code": "BZE",
      "deviceName": "Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer",
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    },
    {
      "code": "CAE",
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    {
      "code": "CAP",
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    {
      "code": "KMA",
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    {
      "code": "LRK",
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    {
      "code": "MQM",
      "deviceName": "Bilirubin (Total And Unbound) In The Neonate Test System",
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    {
      "code": "NPF",
      "deviceName": "Monitor, Apnea, Home Use",
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    },
    {
      "code": "BSJ",
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    },
    {
      "code": "BSK",
      "deviceName": "Cuff, Tracheal Tube, Inflatable",
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    },
    {
      "code": "BSY",
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      "medianReviewDays": 62
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    {
      "code": "BTK",
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  "productCodesTotal": "42",
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    {
      "kNumber": "K243394",
      "deviceName": "AF531 Oro-Nasal SE Face Mask",
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    },
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      "kNumber": "K231313",
      "deviceName": "Therapy Mask 3100 NC/SP",
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    {
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      "deviceName": "Trilogy Evo Universal",
      "productCode": "CBK",
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    "shown": [
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        "name": "RESPIRONICS INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
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      {
        "name": "Respironics , Ltd.",
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      {
        "name": "Respironics Inc. (Dba Philips Respironics)",
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        "method": "normalised"
      },
      {
        "name": "Respironics,  Inc.",
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        "method": "normalised"
      },
      {
        "name": "Respironics, Inc.",
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        "method": "normalised"
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      {
        "name": "Respironics, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Respironics%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Respironics%2C%20Inc.%22"
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  "retrievedAt": "2026-08-11T14:48:53.031Z"
}