{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "199547",
      "product_res_number": "Z-1644-2023",
      "event_date_initiated": "2023-03-06",
      "event_date_posted": "2023-05-26",
      "recall_status": "Open, Classified",
      "res_event_number": "92063",
      "product_code": "DSJ",
      "product_description": "EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01\nProduct Number: 863359",
      "code_info": "UDI: (01)00884838075900\nSoftware Version A.00.02 and A.00.01",
      "firm_fei_number": "3016618143",
      "recalling_firm": "Philips North America Llc",
      "address_1": "222 Jacobs St",
      "city": "Cambridge",
      "state": "MA",
      "postal_code": "02141-2289",
      "additional_info_contact": "Philips Customer Services Worldwide \n800-722-9377",
      "reason_for_recall": "EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.",
      "root_cause_description": "Software design",
      "action": "Philips issued Urgent Field Safety Notice Letter on 3/3/23. Letter states reason for recall, health risk and action to take:\n1. Identify the last calibration date of the device and review your hospital maintenance plan.\nDetermine if your device has E01 End Tidal CO2 and has not been calibrated within one year of\nthe production calibration. If needed adjust the maintenance plan and incorporate the\ncalibration of your affected device.\na. The device should not be used until the calibration or maintenance plan has been\nreviewed.\nb. The calibration date can be accessed via the following steps on the device: Settings >\nAdmin > Diagnostics > Page 2 of Diagnostics > Maintenance > 129 > CO2 Test. The image\nbelow shows the example of the screen to see the last calibration date of your device:\n2. Review this URGENT Field Safety Notice in its entirety and pass this notice to all those who\nneed to be aware within your organization or to any organizations where the potentially\naffected devices have been transferred. (If appropriate).\n3. Complete and return attached form to Philips promptly to confirm receipt of the URGENT Field\nSafety Notice Letter, understanding of the issue, and required actions to be taken.\n4. Actions planned by Philips Hospital Patient Monitoring to correct the problem\nA Philips representative will reach out to you to arrange a software upgrade to your monitor(s).\nPhilips will start to schedule the upgrade upon formal release of the field action, which is planned\nfor a six month implementation timeline.\nIf you need any further information or support concerning this issue, please contact your local Philips representative",
      "product_quantity": "64 units US; 20 units OUS",
      "distribution_pattern": "Nationwide\nForeign:\nBelgium\nBrazil\nCanada\nDenmark\nGermany\nGuam\nHong Kong\nIndonesia\nItaly\nNorway\nPoland\nSingapore\nSweden\nSwitzerland\nUnited Kingdom",
      "openfda": {
        "k_number": [
          "K910262",
          "K960916",
          "K133961",
          "K163649",
          "K151761",
          "K190624"
        ],
        "registration_number": [
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          "3001570235",
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          "3009831876",
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          "3008729547",
          "9610816",
          "3012359877",
          "9710602",
          "3007836437",
          "3007603826",
          "3009001657",
          "3011353843",
          "3019388613",
          "3004415095",
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          "3008483389",
          "3004977335",
          "9681377",
          "3003971136",
          "2221819",
          "3016674095"
        ],
        "fei_number": [
          "3032109181",
          "3013783488",
          "3001570235",
          "1828100",
          "3012528160",
          "3009831876",
          "3000126629",
          "3003513129",
          "3013500228",
          "3003263092",
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          "3002806783",
          "3009001657",
          "3011353843",
          "3019388613",
          "3004415095",
          "3016701404",
          "1000300598",
          "3010698831",
          "3003687189",
          "3005877899",
          "3008058135",
          "3008716327",
          "3013679558",
          "1316463",
          "3009077524",
          "3013596024",
          "3009156722",
          "1218950",
          "3016618143",
          "3014541700",
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          "3008483389",
          "3002737156",
          "3004977335",
          "3002807167",
          "3003971136",
          "2221819",
          "3016674095"
        ],
        "device_name": "Alarm, Blood-Pressure",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1100",
        "device_class": "2"
      }
    }
  ]
}