{
  "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": "2026-04-08",
    "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": "79091",
      "recalling_firm": "Philips Electronics North  America Corporation",
      "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 Nationwide",
      "recall_number": "Z-0717-2018",
      "product_description": "Allura Xper FD and and Xper FD ORT - Philips X-ray Systems    Product Usage:  The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for:   Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for:   Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis.   Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology.   Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally:   The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)",
      "product_quantity": "1486",
      "reason_for_recall": "Extra monitors, so called 7th or 8th monitor, mounted on the Monitor Ceiling Suspension (MCS), might disengage from the MCS and fall down. The two small set screws securing the two gliding rods into an aluminum block of  the support arm can come loose because of vibrations and forces exerted on them.  If the set screws have come loose gravity can keep the rods in position. However, if a force is exerted on the monitor pushing it forward, the monitor can  topple forward. Once the monitor has toppled over it is only attached with its wires. If the monitor breaks loose of its wires it will drop on the floor.",
      "recall_initiation_date": "20171220",
      "center_classification_date": "20180224",
      "termination_date": "20200616",
      "report_date": "20180307",
      "code_info": "All  Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes:  722001      722002      722003 722010 722026  722005 722011 722027  722006 722012 722028  722008 722013    722015 722023 722035  722020      722029      722038      722039      722058      722059"
    }
  ]
}