{
  "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": "221632",
      "product_res_number": "Z-2967-2026",
      "event_date_initiated": "2026-07-20",
      "event_date_posted": "2026-08-14",
      "recall_status": "Open, Classified",
      "res_event_number": "99476",
      "product_code": "KDN",
      "k_numbers": [
        "K234060"
      ],
      "product_description": "Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System\nREF# PRGNX-8008-001",
      "code_info": "All Serial Numbers/UDI: 00850005470342\nSoftware Version: Paragonix App Ver. 6.1.1/6.1.2",
      "firm_fei_number": "3011175555",
      "recalling_firm": "Paragonix Technologies Inc.",
      "address_1": "639 Granite St Ste 408 639 Granite St",
      "address_2": "Ste 408",
      "city": "Braintree",
      "state": "MA",
      "postal_code": "02184-5369",
      "reason_for_recall": "Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.",
      "root_cause_description": "Software design",
      "action": "On July 20, 2026, Paragonix Technologies Inc./Getinge issued an Urgent Medical Device Correction to affected consignees via FedEX mail. Paragonix requested consignees to take the following actions:\n\n1.\tAn update to the Paragonix App has been released through the application store.\n\n2.\tWe recommend updating all mobile devices to latest version prior to KidneyVault usage. \n\n3.\tPlease continue to inspect all KidneyVault devices per the IFU before use to ensure proper datalogger function.\n\n4. Continue to follow the IFU for using a multi-faceted clinical approach to assessing the organ, including any/all information available on the datalogger screen. \n\n5.  Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. \n\n6. Complete and return the enclosed response form by e-mailing a copy to recallresponses.qrc@getinge.com.",
      "product_quantity": "1445 systems",
      "distribution_pattern": "US Nationwide distribution in the states and territories of AL, AZ, CA, TN, FL, HI, MN, NJ, TX, UT, CO, CT, DC, MD, GA, KY, LA, MA, MI, MO, MS, NC, ND, NE, NM, NV, NY, PA, PR, SC, UT, VA, WI, WV, IN, OH, KY, IL, MD, MN, OR.",
      "openfda": {
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          "K243840",
          "K972066",
          "K830994",
          "K202652",
          "K013575",
          "K240650",
          "K143054",
          "K243618",
          "K191006",
          "K073693",
          "K111521",
          "K083453",
          "K191440",
          "K192869",
          "K080432",
          "K211224",
          "K990229",
          "K261644"
        ],
        "registration_number": [
          "3038515260",
          "3007583504",
          "3004068499",
          "3031884833",
          "2183744",
          "3027669473",
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          "3017223202",
          "3000143502",
          "1721676",
          "3010163695",
          "3007710603",
          "1450662"
        ],
        "fei_number": [
          "1000136478",
          "3038515260",
          "3007583504",
          "3001640191",
          "3004068499",
          "3031884833",
          "2183744",
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          "3000143502",
          "1721676",
          "3010163695",
          "3007710603",
          "3001451660",
          "1000221028"
        ],
        "device_name": "System, Perfusion, Kidney",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5880",
        "device_class": "2"
      }
    }
  ]
}