{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 94
    }
  },
  "results": [
    {
      "cfres_id": "35249",
      "product_res_number": "Z-0018-05",
      "event_date_initiated": "2004-09-24",
      "event_date_posted": "2004-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-09-15",
      "res_event_number": "30145",
      "product_code": "NWI",
      "k_numbers": [
        "K032338"
      ],
      "product_description": "Trio Monitor.  Cardiac Monitor (including cardiotachometer and rate alarm).",
      "code_info": "Serial Number:  MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.",
      "firm_fei_number": "2221819",
      "recalling_firm": "Datascope Corp",
      "address_1": "800 MacArthur Blvd",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-2001",
      "additional_info_contact": "Susan E. Mandy\n201-995-8025",
      "reason_for_recall": "Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.",
      "root_cause_description": "Other",
      "action": "Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.",
      "product_quantity": "19",
      "distribution_pattern": "Shipments made to three locations.  These are Medstone Internation, Aliso Viejo, CA; Indiana Eye Clinic, Greenwood, IN; and Sumter Urologoly Assoc., Sumter, SC.",
      "openfda": {
        "registration_number": [
          "1423537",
          "1061124",
          "3009888344",
          "1928237",
          "9616088",
          "3005012805",
          "1643817",
          "3002821232",
          "3016050940",
          "3012447612",
          "3004111573",
          "1528319",
          "3007329020",
          "3042989733"
        ],
        "fei_number": [
          "3001236905",
          "3004111573",
          "3009888344",
          "1000512168",
          "1000122656",
          "1928237",
          "3005012805",
          "1643817",
          "3002821232",
          "3016050940",
          "3012447612",
          "3002902735",
          "3007329020",
          "3042989733"
        ],
        "device_name": "Electrosurgical Electrode Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4300",
        "device_class": "2"
      }
    }
  ]
}