{
  "companyId": "53030",
  "slug": "philips-medical-systems-inc-53030",
  "name": "Philips Medical Systems, Inc.",
  "clearances": {
    "total": 218,
    "last12Months": 0,
    "first": "1983-10-28",
    "latest": "2021-09-24"
  },
  "medianReviewDays": 73,
  "productCodeCount": 53,
  "recalls": {
    "total": 179,
    "openLast12Months": 7,
    "recent": [
      {
        "resNumber": "Z-2650-2026",
        "productCode": "JAK",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-11",
        "reason": "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation."
      },
      {
        "resNumber": "Z-2651-2026",
        "productCode": "JAK",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-11",
        "reason": "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation."
      },
      {
        "resNumber": "Z-2652-2026",
        "productCode": "JAK",
        "status": "Open, Classified",
        "recallClass": null,
        "initiated": "2026-06-11",
        "reason": "The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation."
      },
      {
        "resNumber": "Z-1825-2026",
        "productCode": "JAK",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-03-07",
        "reason": "Philips has identified three software issues:\n1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. \n2. Potential where the message of Previous Surview Exists Select Previous Surview?  or  should display but does not appear. \n3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out."
      },
      {
        "resNumber": "Z-0375-2026",
        "productCode": "JAK",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-09-25",
        "reason": "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop.\nIssue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the\nWED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient\ndose setting after the surview. If operator misses the insufficient dose and the WED value in User\nInterface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting.\nIssue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient.\nIssue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images.\nIssue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient.\nIssue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan.\nThere is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process."
      }
    ]
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
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    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
      "clearances": 32,
      "latest": "2019-08-06",
      "medianReviewDays": 30
    },
    {
      "code": "MKJ",
      "deviceName": "Automated External Defibrillators (Non-Wearable)",
      "clearances": 17,
      "latest": "2015-01-23",
      "medianReviewDays": 107
    },
    {
      "code": "LNH",
      "deviceName": "System, Nuclear Magnetic Resonance Imaging",
      "clearances": 16,
      "latest": "2007-01-04",
      "medianReviewDays": 194
    },
    {
      "code": "LLZ",
      "deviceName": "System, Image Processing, Radiological",
      "clearances": 14,
      "latest": "2010-01-08",
      "medianReviewDays": 64
    },
    {
      "code": "IYE",
      "deviceName": "Accelerator, Linear, Medical",
      "clearances": 11,
      "latest": "1996-12-06",
      "medianReviewDays": 86
    },
    {
      "code": "MWI",
      "deviceName": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
      "clearances": 10,
      "latest": "2009-12-18",
      "medianReviewDays": 13
    },
    {
      "code": "DPS",
      "deviceName": "Electrocardiograph",
      "clearances": 9,
      "latest": "2021-06-30",
      "medianReviewDays": 58
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 8,
      "latest": "2007-04-27",
      "medianReviewDays": 72
    },
    {
      "code": "JAK",
      "deviceName": "System, X-Ray, Tomography, Computed",
      "clearances": 8,
      "latest": "2014-09-25",
      "medianReviewDays": 94
    },
    {
      "code": "IZI",
      "deviceName": "System, X-Ray, Angiographic",
      "clearances": 6,
      "latest": "2002-10-30",
      "medianReviewDays": 67
    },
    {
      "code": "MSX",
      "deviceName": "System, Network And Communication, Physiological Monitors",
      "clearances": 6,
      "latest": "2016-06-24",
      "medianReviewDays": 90
    },
    {
      "code": "DSI",
      "deviceName": "Detector And Alarm, Arrhythmia",
      "clearances": 5,
      "latest": "2011-11-17",
      "medianReviewDays": 24
    },
    {
      "code": "OWB",
      "deviceName": "Interventional Fluoroscopic X-Ray System",
      "clearances": 5,
      "latest": "2003-07-17",
      "medianReviewDays": 33
    },
    {
      "code": "DRG",
      "deviceName": "Transmitters And Receivers, Physiological Signal, Radiofrequency",
      "clearances": 4,
      "latest": "2020-04-16",
      "medianReviewDays": 28
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 4,
      "latest": "2012-02-14",
      "medianReviewDays": 29
    },
    {
      "code": "IYN",
      "deviceName": "System, Imaging, Pulsed Doppler, Ultrasonic",
      "clearances": 4,
      "latest": "2021-09-24",
      "medianReviewDays": 29
    },
    {
      "code": "JAA",
      "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified",
      "clearances": 4,
      "latest": "2002-03-15",
      "medianReviewDays": 64
    },
    {
      "code": "OXO",
      "deviceName": "Image-Intensified Fluoroscopic X-Ray System, Mobile",
      "clearances": 4,
      "latest": "2001-04-02",
      "medianReviewDays": 29
    },
    {
      "code": "HAW",
      "deviceName": "Neurological Stereotaxic Instrument",
      "clearances": 3,
      "latest": "1999-01-28",
      "medianReviewDays": 224
    },
    {
      "code": "IYO",
      "deviceName": "System, Imaging, Pulsed Echo, Ultrasonic",
      "clearances": 3,
      "latest": "1993-12-10",
      "medianReviewDays": 477
    },
    {
      "code": "BSZ",
      "deviceName": "Gas-Machine, Anesthesia",
      "clearances": 2,
      "latest": "2008-12-18",
      "medianReviewDays": 30
    },
    {
      "code": "DRW",
      "deviceName": "Adaptor, Lead Switching, Electrocardiograph",
      "clearances": 2,
      "latest": "2004-01-15",
      "medianReviewDays": 70
    },
    {
      "code": "DSJ",
      "deviceName": "Alarm, Blood-Pressure",
      "clearances": 2,
      "latest": "2017-03-31",
      "medianReviewDays": 98
    },
    {
      "code": "DXJ",
      "deviceName": "Display, Cathode-Ray Tube, Medical",
      "clearances": 2,
      "latest": "2015-10-30",
      "medianReviewDays": 75
    },
    {
      "code": "FPD",
      "deviceName": "Tube, Feeding",
      "clearances": 2,
      "latest": "2013-10-23",
      "medianReviewDays": 145
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "53",
  "recentClearances": [
    {
      "kNumber": "K212704",
      "deviceName": "Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System",
      "productCode": "IYN",
      "decisionDate": "2021-09-24",
      "reviewDays": 29
    },
    {
      "kNumber": "K211597",
      "deviceName": "EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System",
      "productCode": "IYN",
      "decisionDate": "2021-09-08",
      "reviewDays": 107
    },
    {
      "kNumber": "K210560",
      "deviceName": "Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph",
      "productCode": "DPS",
      "decisionDate": "2021-06-30",
      "reviewDays": 125
    },
    {
      "kNumber": "K191738",
      "deviceName": "PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph",
      "productCode": "DPS",
      "decisionDate": "2020-09-29",
      "reviewDays": 459
    },
    {
      "kNumber": "K192875",
      "deviceName": "Philips Biosensor BX100",
      "productCode": "DRG",
      "decisionDate": "2020-04-16",
      "reviewDays": 191
    },
    {
      "kNumber": "K183387",
      "deviceName": "M3290B Patient Information Center iX",
      "productCode": "MHX",
      "decisionDate": "2019-08-06",
      "reviewDays": 243
    },
    {
      "kNumber": "K180017",
      "deviceName": "MX40 Release C.01",
      "productCode": "MHX",
      "decisionDate": "2018-07-24",
      "reviewDays": 203
    },
    {
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      "deviceName": "MX40 Release B.07",
      "productCode": "MHX",
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    },
    {
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      "deviceName": "M3290B Philips IntelliVue Information Center iX",
      "productCode": "MHX",
      "decisionDate": "2017-07-07",
      "reviewDays": 199
    },
    {
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      "deviceName": "SureSigns VS3; SureSigns VS4",
      "productCode": "DSJ",
      "decisionDate": "2017-03-31",
      "reviewDays": 98
    }
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    "shown": [
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        "name": "PHILIPS MEDICAL SYSTEMS",
        "dataset": "device/recall",
        "method": "normalised"
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        "method": "normalised"
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      {
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        "method": "normalised"
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      {
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      {
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        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Philips Medical Systems, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
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        "name": "Philips Medical Systems, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Philips%20Medical%20Systems%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Philips%20Medical%20Systems%2C%20Inc.%22"
  },
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      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
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    {
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      "loadedAt": "2026-08-10T06:54:18Z",
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      "loadedAt": "2026-08-10T19:40:12Z",
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    {
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      "loadedAt": "2026-08-11T13:58:22Z",
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      "loadedAt": "2026-08-10T19:40:11Z",
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    {
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      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.028Z"
}