{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Winter Park",
      "address_1": "7457 Aloma Ave",
      "reason_for_recall": "The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup.  This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.",
      "address_2": "Suite 201",
      "product_quantity": "176 individuals kits",
      "code_info": "Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.",
      "center_classification_date": "20130802",
      "distribution_pattern": "Worldwide distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, and WA; and countries of: Australia, Austria, Denmark, Epsom, France, Germany, London, Netherlands, Saudia Arabia, and United Kingdom.",
      "state": "FL",
      "product_description": "MRidium 1145 Dose Reduction System (DERS) drug library kit.  (This is an option for the MRidium 3860+MR Infusion Pump System).    The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.",
      "report_date": "20130814",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Iradimed Corporation",
      "recall_number": "Z-1874-2013",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "65778",
      "termination_date": "20150713",
      "recall_initiation_date": "20130701",
      "postal_code": "32792-9172",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}