{
  "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": "221445",
      "product_res_number": "Z-2928-2026",
      "event_date_initiated": "2026-06-29",
      "event_date_posted": "2026-08-10",
      "recall_status": "Open, Classified",
      "res_event_number": "99378",
      "product_code": "OWB",
      "k_numbers": [
        "K133292",
        "K141979",
        "K161563",
        "K162859"
      ],
      "product_description": "Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058.\n\nInterventional fluoroscopic x-ray system.",
      "code_info": "Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. 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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": "Firmware issue potentially leading to loss of geometry movements.",
      "root_cause_description": "Software design",
      "action": "Philips notified consignees on about 06/29/2026 via certified mailed letter titled URGENT Medical Device Correction. Consignees were provided instructions to properly identify affected systems and table configurations, instructions for restarting the geometry when the issue occurs, to ensure the notification is distributed to all relevant users and retained with device documentation until corrective actions are completed. Consignees were also instructed to post the notification letter near affected devices for ease of reviewing, notify recipients if affected units were transferred, and to complete and return the provided response form. A Local Philips representative will contact consignees to schedule a visit for the implementation of the software update once available. \n\nPhilips will address the identified issues by implementing a software update (R8.2.102.1) in all affected systems (FCO72200674). Philips currently expects R8.2.102.1 to be available by Q1 2027, subject to regulatory clearance.",
      "product_quantity": "4,252 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.",
      "openfda": {
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