{
  "companyId": "53536",
  "slug": "philips-medical-systems-north-america-inc-53536",
  "name": "Philips Medical Systems North America Inc.",
  "clearances": {
    "total": 95,
    "last12Months": 0,
    "first": "1989-04-20",
    "latest": "2010-09-30"
  },
  "medianReviewDays": 63,
  "productCodeCount": 28,
  "recalls": {
    "total": 5,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1263-2014",
        "productCode": "IYN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-02-28",
        "reason": "A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System.  The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom  Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by"
      },
      {
        "resNumber": "Z-1264-2014",
        "productCode": "IYN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-02-28",
        "reason": "A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System.  The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom  Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated b"
      },
      {
        "resNumber": "Z-1225-2014",
        "productCode": "MKJ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-02-06",
        "reason": "Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency."
      },
      {
        "resNumber": "Z-1232-2014",
        "productCode": "MKJ",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2014-02-06",
        "reason": "Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency."
      },
      {
        "resNumber": "Z-0368-2014",
        "productCode": "IYN",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-10-17",
        "reason": "A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD)."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
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    {
      "code": "LNH",
      "deviceName": "System, Nuclear Magnetic Resonance Imaging",
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      "latest": "2005-02-15",
      "medianReviewDays": 81
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
      "clearances": 16,
      "latest": "2010-09-30",
      "medianReviewDays": 64
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 10,
      "latest": "2001-10-01",
      "medianReviewDays": 57
    },
    {
      "code": "IZI",
      "deviceName": "System, X-Ray, Angiographic",
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      "latest": "2006-04-04",
      "medianReviewDays": 49
    },
    {
      "code": "OWB",
      "deviceName": "Interventional Fluoroscopic X-Ray System",
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      "latest": "2010-08-09",
      "medianReviewDays": 25
    },
    {
      "code": "JAA",
      "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified",
      "clearances": 4,
      "latest": "2005-04-08",
      "medianReviewDays": 80
    },
    {
      "code": "KPR",
      "deviceName": "System, X-Ray, Stationary",
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      "latest": "2005-02-09",
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    },
    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
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      "latest": "2008-10-08",
      "medianReviewDays": 44
    },
    {
      "code": "MOS",
      "deviceName": "Coil, Magnetic Resonance, Specialty",
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      "latest": "2002-01-18",
      "medianReviewDays": 56
    },
    {
      "code": "IYE",
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      "medianReviewDays": 192
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    {
      "code": "IZH",
      "deviceName": "System, X-Ray, Mammographic",
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      "latest": "1990-01-31",
      "medianReviewDays": 142
    },
    {
      "code": "IZL",
      "deviceName": "System, X-Ray, Mobile",
      "clearances": 2,
      "latest": "2006-09-15",
      "medianReviewDays": 34
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
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      "latest": "2006-10-18",
      "medianReviewDays": 72
    },
    {
      "code": "DXK",
      "deviceName": "Echocardiograph",
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      "latest": "1990-04-02",
      "medianReviewDays": 90
    },
    {
      "code": "ITX",
      "deviceName": "Transducer, Ultrasonic, Diagnostic",
      "clearances": 1,
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    {
      "code": "IWE",
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      "medianReviewDays": 27
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    {
      "code": "IXR",
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    {
      "code": "IZO",
      "deviceName": "Generator, High-Voltage, X-Ray, Diagnostic",
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    },
    {
      "code": "IZP",
      "deviceName": "Programmer, Changer, Film/Cassette, Radiographic",
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      "latest": "1991-10-15",
      "medianReviewDays": 169
    },
    {
      "code": "IZW",
      "deviceName": "Collimator, Automatic, Radiographic",
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      "latest": "2003-07-21",
      "medianReviewDays": 61
    },
    {
      "code": "KPQ",
      "deviceName": "System, Simulation, Radiation Therapy",
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      "latest": "1989-04-20",
      "medianReviewDays": 41
    },
    {
      "code": "KXJ",
      "deviceName": "Table, Radiologic",
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      "latest": "1994-03-16",
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    },
    {
      "code": "LMB",
      "deviceName": "Device, Digital Image Storage, Radiological",
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      "medianReviewDays": 134
    },
    {
      "code": "LMD",
      "deviceName": "System, Digital Image Communications, Radiological",
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      "latest": "1996-04-07",
      "medianReviewDays": 39
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  "productCodesTotal": "28",
  "recentClearances": [
    {
      "kNumber": "K101311",
      "deviceName": "EP NAVIGATOR R3",
      "productCode": "LLZ",
      "decisionDate": "2010-09-30",
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    },
    {
      "kNumber": "K102005",
      "deviceName": "ALLURA XPER OR TABLE SERIES",
      "productCode": "OWB",
      "decisionDate": "2010-08-09",
      "reviewDays": 25
    },
    {
      "kNumber": "K090625",
      "deviceName": "WIRELESS PORTABLE DETECTOR FD-W17",
      "productCode": "MQB",
      "decisionDate": "2009-03-24",
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    },
    {
      "kNumber": "K090590",
      "deviceName": "VERADIUS, MODEL 718-130",
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      "decisionDate": "2009-03-16",
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    },
    {
      "kNumber": "K082280",
      "deviceName": "SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR",
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      "decisionDate": "2008-10-08",
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    {
      "kNumber": "K063781",
      "deviceName": "PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE",
      "productCode": "LLZ",
      "decisionDate": "2007-01-05",
      "reviewDays": 15
    },
    {
      "kNumber": "K062233",
      "deviceName": "HEARTSTART MRX MONITOR/DEFIBRILLATOR",
      "productCode": "MKJ",
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    {
      "kNumber": "K062268",
      "deviceName": "MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03",
      "productCode": "DQA",
      "decisionDate": "2006-10-18",
      "reviewDays": 72
    },
    {
      "kNumber": "K062283",
      "deviceName": "THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS",
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      "decisionDate": "2006-09-15",
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        "name": "Philips Medical Systems North America Co.",
        "dataset": "device/510k",
        "method": "normalised"
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        "name": "Philips Medical Systems North America Inc.",
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      }
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Philips%20Medical%20Systems%20North%20America%20Inc.%22",
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}