{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85399",
      "recalling_firm": "Philips North  America, LLC",
      "address_1": "3000 Minuteman Rd",
      "address_2": "N/A",
      "postal_code": "01810-1032",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.  US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands  New Zealand, South Africa, Switzerland, Thailand",
      "recall_number": "Z-1809-2020",
      "product_description": "Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the  Azurion R2.0 system         Interventional fluoroscopic x-ray system   System code:  722079",
      "product_quantity": "22 units (6 US and 16 OUS); Expanded 3units; Total: 25",
      "reason_for_recall": "When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.",
      "recall_initiation_date": "20200403",
      "center_classification_date": "20200429",
      "termination_date": "20230201",
      "report_date": "20200506",
      "code_info": "Software:Philips Azurion 2.0 Interventional Fluoroscopic X-ray system with  Interventional Workspot 1.5    US Serial Numbers: 637, 200, 909, 1276, 1309, 987    Canada: 1016     ROW:  11169  1129  1143  971  1135  824  934  1089  1008  1165  1080  1019  1248  523  1172    Expanded Recall OUS:  1223, 1330, 703424"
    }
  ]
}