{
  "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": "2026-04-15",
    "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": "69339",
      "recalling_firm": "Philips Medical Systems, Inc.",
      "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) and Internationally to:  CZECH REPUBLIC  ALBANIA  ALGERIA  ARGENTINA  AUSTRALIA  AUSTRIA  AZARBAIJAN  BAHAMAS  BANGLADESH  BELGIUM  BRAZIL  BULGARIA  CAYMAN ISLANDS  CHILE  CHINA  COLUMBIA  COSTA RICA  CROATIA  CUBA  CZECHOSLOVAKIA  DENMARK  DOMINICAN REPUB  ECUADOR  EGYPT  ESTONIA  FINLAND  FRANCE  GABON  GERMANY  GREECE  HONG KONG  HUNGARY  ICELAND  INDIA  INDONESIA  IRAN  IRAQ  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KAZAKHSTAN  KENYA  KOREA SOUTH  KUWAIT  LATVIA  LEBANON  LIBYA  LITHUANIA  MACEDONIA  MALAYSIA  MAURITIUS  MEXICO  MOLDAVIA  MONGOLIA  MOROCCO  NEPAL  NETHERLANDS  NETHERLANDS ANT  NEW ZEALAND  NORWAY  OMAN  PAKISTAN  PALESTINE  PANAMA  Papua New Guinea  PARAGUAY  PERU  PHILIPPINES  POLAND  PORTUGAL  PUORTO RICO  QATAR  REUNION  ROMANIA  RUSSIAN FEDERAT  SAUDI ARABIA  SERBIA  SINGAPORE  SLOVENIA  SOUTH AFRICA  SPAIN  SUDAN  SWEDEN  SWITZERLAND  SYRIA  TAIWAN  TANZANIA  THAILAND  TUNISIA  TURKEY  UKRAINE  UNITED ARAB EMI  United Arab Emirates  UNITED KINGDOM  URUGUAY  USA  UZBEKISTAN  VENEZUELA  VIETNAM  YEMEN  GUADELOUPE  SYRIAN ARAB REPUBLIC",
      "recall_number": "Z-1280-2016",
      "product_description": "Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table, 722025 Allura Xper FD2O Biplane OR Table, 722026 Allura Xper FD1O, 722027 Allura Xper FD1O/10, 722028 Allura Xper FD2O, 722029 Allura Xper FD2O/10, 722031 Allura CV2O, 722033 Allura Xper FD1O OR Table, 722034 Allura Xper FD1O/10 OR Table, 722035 Allura Xper FD2O OR Table, 722036 Allura Xper FD2O/10 OR Table, 722038 Allura Xper FD2O/20, 722039 Allura Xper FD2O/20 OR Table, 722058 Allura Xper FD20115, 722059 Allura Xper FD2O/15 OR Table, 722123 Field extensions Xper cardio systems, 722124 Field extensions Xper vascular systems, 722126 SmartPath to AlluraClarity cardio, 722127 SmartPath to AlluraClarity vascular, 722133 Field ext. Xper cardio systems R7.6, 722134 Field ext. Xper vascular systems R7.6, 722400 Cardio Vascular-Allura Centron, 889006 Diamond Select Allura Xper FD1 0  The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Tis included, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room. FD10 is compatible with specific magnetic navigation systems",
      "product_quantity": "4180 devices",
      "reason_for_recall": "Loss of key image functionality due to a bent pedal of the Footswitch.",
      "recall_initiation_date": "20140924",
      "center_classification_date": "20160331",
      "termination_date": "20190326",
      "report_date": "20160406",
      "code_info": "Foot Switches:  452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m;  452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2;  459800415531 Wireless Footswitch 3P;  459800415561 Wireless footswitch set 3P."
    }
  ]
}