{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "188408",
      "product_res_number": "Z-2287-2021",
      "event_date_initiated": "2021-07-26",
      "event_date_created": "2021-08-13",
      "recall_status": "Open, Classified",
      "res_event_number": "88333",
      "product_code": "NOU",
      "k_numbers": [
        "K181166"
      ],
      "product_description": "Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B",
      "code_info": "Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02",
      "firm_fei_number": "2518422",
      "recalling_firm": "Philips Respironics, Inc.",
      "address_1": "1001 Murry Ridge Ln",
      "city": "Murrysville",
      "state": "PA",
      "postal_code": "15668-8517",
      "additional_info_contact": "Philips Customer Service\n800-722-9377",
      "reason_for_recall": "Two software issues have been identified related to pressure increase in the device: The first issue is described as \"Infant/Pediatric EFS Calibration Pressure Increase\" and the second issue is described as \"Pressure Drift (Continuous Usage).",
      "root_cause_description": "Labeling design",
      "action": "On July 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were advised of the two software issues that the firm had identified related to pressure increase. Customers received guidance on how to identify affected products: Devices with software versions devices with software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01 and 1.06.02 are impacted.\n\nCustomers were provided with actions to take until the upcoming software fix is implemented on your device.\n\nPhilips will be releasing a software correction to resolve this issue, and will contact customers when the software correction is released.\n\nIf you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center \n\nTrilogy Evo: +1-800-345-6443 Option 2, Option 1 (Available 24/7)\nTrilogy EV300: +1-800-722-9377 (Available 24/7)",
      "product_quantity": "18588 (US); 5662 (OUS)",
      "distribution_pattern": "Worldwide distribution - US nationwide distribution.",
      "openfda": {
        "k_number": [
          "K022750",
          "K233452",
          "K193586",
          "K160481",
          "K123144",
          "K034032",
          "K021981"
        ],
        "device_name": "Continuous, Ventilator, Home Use",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5895",
        "device_class": "2",
        "registration_number": [
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