{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216374",
      "product_res_number": "Z-0410-2026",
      "event_date_initiated": "2025-09-26",
      "event_date_posted": "2025-10-29",
      "recall_status": "Open, Classified",
      "res_event_number": "97707",
      "product_code": "DPW",
      "k_numbers": [
        "K102595"
      ],
      "product_description": "Brand Name: Medistim MiraQ System\nProduct Name: Medistim MiraQ System\nModel/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011\nSoftware Version: Not applicable\nProduct Description: Ultrasound device for intraoperative use\nComponent: No",
      "code_info": "Lot Code: Serial number; Model number\n5042; MQC04001\n5043; MQC04001\n5044; MQC14001\n5061; MQU14011\n5062; MQU14011\n5064; MQU14011\n5065; MQU14011\n5066; MQU14011\n5067; MQC04001\n5037; MQU14011\n5073; MQV12011\n5038; MQU14011\n5045; MQU14011\n5063; MQU14011",
      "firm_fei_number": "3010790133",
      "recalling_firm": "Medistim Asa",
      "address_1": "Okernveien 94 94 okernveien",
      "city": "Oslo",
      "country": "Norway",
      "additional_info_contact": "Kari Krogstad\n+47 23 05 96 60",
      "reason_for_recall": "Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.",
      "root_cause_description": "Process control",
      "action": "Firm notified impacted consignees by email on September 26, 2025. Consignees were informed that qualified service personnel will perform the correction of the device according to the standard service procedure.",
      "product_quantity": "14",
      "distribution_pattern": "Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.",
      "openfda": {
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        "registration_number": [
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        ],
        "device_name": "Flowmeter, Blood, Cardiovascular",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2100",
        "device_class": "2"
      }
    }
  ]
}