{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "210674",
      "product_res_number": "Z-0501-2025",
      "event_date_initiated": "2024-10-15",
      "event_date_posted": "2024-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "95581",
      "product_code": "QQK",
      "pma_numbers": [
        "P200035"
      ],
      "product_description": "OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers.\n\nModel/Catalog Number: D0003\n\nThe OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.",
      "code_info": "UDI-DI:  05060462240029\n\nSerial numbers 511, 512, 514, 515, 516, 517, 518, 519, 520, 522, 523, 524, 525, 527, 528, 529, 530, 531, 533, 535, 536, 537",
      "firm_fei_number": "3011560054",
      "recalling_firm": "OrganOx Ltd",
      "address_1": "1 magdalen centre robert robinson avenue",
      "city": "Oxford",
      "country": "United Kingdom",
      "additional_info_contact": "Jeff Fecho \n973-5544393",
      "reason_for_recall": "Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket",
      "root_cause_description": "Device Design",
      "action": "OrganOx issued  Important Field Correction Notice letter on 10/15/24 via Fed'X. letter states reason for recall, health risk and action to take:\nAs a result of the investigation into this event, OrganOx has implemented a secondary battery retention mechanism to prevent battery movement due to jarring or impact that could be related to machine transport or movement. The secondary battery retention mechanism will be installed on your machine by OrganOx service personnel no later than 15 December 2024.\nRecommendations:\nThe metra in your possession continues to be safe and effective in anticipation of this correction and the machine may be used as normal. Should an unexpected rapid decrease in battery voltage occur as noted by alarm from the metra, please determine the impact to the perfusion event and take action if needed. Should this occur, please follow the OrganOx complaints reporting process and quarantine the machine until it can be serviced.\n\nShould you have questions about this important Field Correction please contact:\nMichael Donahue\nMichael.donahue@organox.com\n+1 732-948-2175",
      "product_quantity": "20 units",
      "distribution_pattern": "California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.",
      "openfda": {
        "pma_number": [
          "P200035",
          "P200031"
        ],
        "device_name": "Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "3002808022",
          "3006946348",
          "3011560054",
          "2518435",
          "9611296",
          "3003152463",
          "1047843",
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          "1220477"
        ],
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          "3002809568",
          "3002808022",
          "3006946348",
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          "2518435",
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          "1047843",
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        ]
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    }
  ]
}