{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Best",
      "state": "N/A",
      "country": "Netherlands",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92165",
      "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.",
      "address_1": "Veenpluis 4-6",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide  Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen",
      "recall_number": "Z-1647-2023",
      "product_description": "Philips Azurion System  with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6.  Models/Model Number:   (1) Azurion 3M12:\t722063, 722221;  (2) Azurion 3M15:\t722064, 722222;  (3) Azurion SM12:\t722227;  (4) Azurion SM20:\t722228;  (5) Azurion 7B12/12: 722067, 722225;  (6) Azurion 7820/15:\t722068, 722226;  (7) Azurion 7M12:\t722078, 722223;  (8) Azurion 7M20\t:\t722079, 722224",
      "product_quantity": "USA:  \t1063 R.O.W. \t 2136",
      "reason_for_recall": "Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available  there will be a sudden interruption of the procedure",
      "recall_initiation_date": "20230321",
      "center_classification_date": "20230526",
      "report_date": "20230607",
      "code_info": "UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063  (01)00884838085275(21)  722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion  SM12:  722227 (01)00884838099227(21); (4) Azurion  SM20:  722228 (01)00884838099234(21); (5) Azurion  7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15:  722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12:  722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21),     Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6"
    }
  ]
}