{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221532",
      "product_res_number": "Z-2932-2026",
      "event_date_initiated": "2026-07-16",
      "event_date_posted": "2026-08-10",
      "recall_status": "Open, Classified",
      "res_event_number": "99423",
      "product_code": "OWB",
      "k_numbers": [
        "K200917"
      ],
      "product_description": "Philips Azurion, Model Numbers:  722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers:  R3.0 and R3.1; Interventional fluoroscopic x-ray system",
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      "firm_fei_number": "3042175844",
      "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
      "address_1": "Veenpluis 6 6 veenpluis",
      "city": "Best",
      "country": "Netherlands",
      "reason_for_recall": "Two software related issues affecting Philips Azurion R3.0 and R3.1 systems:  \n1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment \nand  \n2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.",
      "root_cause_description": "Software design",
      "action": "Philips issued an URGENT Medical Device Correction to its consignees on 7/16/2026 via certified mailing.  The notice explained the issues, potential harms associated with the issues, and provide instructions for the safe operations of the device pending a software update.  The instructions are as follows:   \nIssue 1: Image quality degradation  \nIf image quality degradation is observed, perform a cold restart of the system as soon as\nclinically feasible, following the steps described in the Instructions for Use:\no On the Review Module, press and hold  Power Off .  \no Release the button when the indicator light begins to flash.  \no When the indicator light stops flashing, wait for 10 seconds.  \no On the Review Module, press and hold  Power On .  \nNOTE: A cold restart of the system takes up to 6 minutes from initiation of the cold restart until all system functionality is available.  \n\" Issue 2: Loss of geometry movements  \nIf loss of geometry movements is observed, restart the geometry following the steps described in the Instructions for Use:  \no On the Control Module, press the  Emergency Stop  button.  \no On the Review Module, press the  Power On  button for approximately 2 seconds.  \n    NOTE: A geometry restart may take up to 2 minutes to complete.\n\" Ensure this notice is distributed to all relevant users of the system.  \n\" Post this notice near affected devices for ease of reference, where applicable.  \n\" If the affected device has been transferred to another organization, please forward this notice to that organization and inform Philips through your local representative.  \n\" Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system.  \n\" If you experience an issue described in this letter, please report it to your local Philips\nrepresentative.  \n\" Complete and return the response form included in this Urgent Medical Device Correction to Philips promptly and no later than 30 days from receipt. Completing t",
      "product_quantity": "2016 units",
      "distribution_pattern": "Worldwide distribution.",
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        "device_name": "Interventional Fluoroscopic X-Ray System",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1650",
        "device_class": "2"
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    }
  ]
}