{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "167365",
      "product_res_number": "Z-0519-2019",
      "event_date_initiated": "2018-08-31",
      "event_date_created": "2018-11-29",
      "recall_status": "Open, Classified",
      "res_event_number": "81058",
      "product_code": "MHZ",
      "k_numbers": [
        "K992929"
      ],
      "product_description": "Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.",
      "code_info": "All monitors",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "Mr. Ben Fox\n414-721-4013",
      "reason_for_recall": "The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.",
      "root_cause_description": "Software design",
      "action": "The recalling firm issued letters dated 8/31/2018 via FedEx on 8/31/2018 informing the customer of the issue and providing safety instructions for mitigation of the issue if a prolonged network overload occurs and the Dash and/or Solar patient monitor on the network does not resume normal functionality in approximately 90 seconds.",
      "product_quantity": "Approximately 182,640 monitoring systems for Dash 3000/4000/5000",
      "distribution_pattern": "Distribution was made nationwide, including Puerto Rico, Guam, and Samoa.  There was also government and military distribution.\n\nForeign distribution was made to Canada, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cameroon, Chile, China, Colombia, Costa Rica, Cota D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuadore, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands,  New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of Serbia, Reunion, Romania, Russia, Saint Lucia, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Yugoslavia, and Zimbabwe.",
      "openfda": {
        "k_number": [
          "K843355"
        ],
        "device_name": "Stimulator, Vestibular Acceleration, Therapeutic",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}