{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "San Diego",
      "address_1": "9833 Pacific Heights Blvd",
      "reason_for_recall": "Incorrect CO2 readings with some patient monitors.",
      "address_2": "",
      "product_quantity": "521",
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260724-M16305050089 USA  83.60.260724 iM60 260724-M16305050090 USA  83.60.260724 iM60 260724-M16305050091 USA  83.60.260724 iM60 260724-M16305050092 USA  83.60.260724 iM60 260724-M16305050093 USA  83.60.260724 iM60 260724-M16305050094 USA  83.60.260724 iM60 260724-M16305050095 USA  83.60.260724 iM60 260724-M16305050096 USA  83.60.260724 iM60 260724-M16305050097 USA  83.60.260724 iM60 260724-M16305050098 USA  83.60.260724 iM60 260724-M16305050099 USA  83.60.260724 iM60 260724-M16305050100 USA  83.60.260724 iM60 260724-M16603500001 USA  83.60.260724 iM60 260724-M16603500002 USA  83.60.260724 iM60 260724-M16603500003 USA  83.60.260724 iM60 260724-M16603500004 USA  83.60.260724 iM60 260724-M16603500005 USA  83.60.260724 iM60 260724-M16603500006 USA  83.60.260724 iM60 260724-M16603500007 USA  83.60.260724 iM60 260724-M16603500008 USA  83.60.260724 iM60 260724-M16603500009 USA  83.60.260724 iM60 260724-M16603500010 USA  83.60.260724 iM60 260724-M16603500011 USA  83.60.260724 iM60 260724-M16603500012 USA  83.60.260724 iM60 260724-M16603500013 USA  83.60.260724 iM60 260724-M16603500014 USA  83.60.260724 iM60 260724-M16603500015 USA  83.60.260736 iM70 260736-M16309420001 Italy  83.60.260736 iM70 260736-M16309420002 Italy  83.60.260736 iM70 260736-M16309420003 Italy  83.60.260752 iM60 VET 260752-M16313610001 United Kingdom  83.60.260752 iM60 VET 260752-M16313610002 United Kingdom  83.60.260752 iM60 VET 260752-M16313610003 United Kingdom  83.60.260752 iM60 VET 260752-M16313610004 United Kingdom  83.60.260752 iM60 VET 260752-M16313610005 United Kingdom  83.60.260753 iM70 VET 260753-M16313620001 United Kingdom  83.60.260753 iM70 VET 260753-M16313620002 United Kingdom  83.60.260753 iM70 VET 260753-M16313620003 United Kingdom  83.60.260753 iM70 VET 260753-M16313620004 United Kingdom  83.60.260753 iM70 VET 260753-M16313620005 United Kingdom  83.60.260753 iM70 VET 260753-M16313620006 United Kingdom  83.60.260753 iM70 VET 260753-M16313620007 United Kingdom  83.60.260753 iM70 VET 260753-M16313620008 United Kingdom  83.60.260793 iM60 VET 260793-M16502000001 United Kingdom  83.60.260793 iM60 VET 260793-M16502000002 United Kingdom  83.60.260793 iM60 VET 260793-M16502000003 United Kingdom  83.60.260793 iM60 VET 260793-M16502000004 United Kingdom  83.60.260793 iM60 VET 260793-M16502000005 United Kingdom  83.60.260793 iM60 VET 260793-M16502000006 United Kingdom  83.60.260793 iM60 VET 260793-M16502000007 United Kingdom  83.60.260793 iM60 VET 260793-M16502000008 United Kingdom  83.60.260793 iM60 VET 260793-M16502000009 United Kingdom  83.60.260793 iM60 VET 260793-M16502000010 United Kingdom  83.60.260793 iM60 VET 260793-M16502000011 United Kingdom  83.60.260793 iM60 VET 260793-M16502000012 United Kingdom  83.60.260793 iM60 VET 260793-M16502000013 United Kingdom  83.60.260793 iM60 VET 260793-M16502000014 United Kingdom  83.60.260793 iM60 VET 260793-M16502000015 United Kingdom  83.60.260793 iM60 VET 260793-M16502000016 United Kingdom  83.60.260793 iM60 VET 260793-M16502000017 United Kingdom  83.60.260793 iM60 VET 260793-M16502000018 United Kingdom  83.60.260793 iM60 VET 260793-M16502000019 United Kingdom  83.60.260793 iM60 VET 260793-M16502000020 United Kingdom  83.60.260793 iM60 VET 260793-M16502000021 United Kingdom  83.60.260793 iM60 VET 260793-M16502000022 United Kingdom  83.60.260793 iM60 VET 260793-M16502000023 United Kingdom  83.60.260793 iM60 VET 260793-M16502000024 United Kingdom  83.60.260793 iM60 VET 260793-M16502000025 United Kingdom  83.60.260793 iM60 VET 260793-M16507740001 United Kingdom  83.60.260793 iM60 VET 260793-M16507740002 United Kingdom  83.60.260793 iM60 VET 260793-M16507740003 United Kingdom  83.60.260793 iM60 VET 260793-M16507740004 United Kingdom  83.60.260793 iM60 VET 260793-M16507740005 United Kingdom  83.60.260793 iM60 VET 260793-M16507740006 United Kingdom  83.60.260793 iM60 VET 260793-M16507740007 United Kingdom  83.60.260793 iM60 VET 260793-M16507740008 United Kingdom  83.60.260793 iM60 VET 260793-M16507740009 United Kingdom  83.60.260793 iM60 VET 260793-M16507740010 United Kingdom  83.60.260794 iM70 VET 260794-M16507550001 United Kingdom  83.60.260794 iM70 VET 260794-M16507550002 United Kingdom  83.60.260794 iM70 VET 260794-M16507550003 United Kingdom  83.60.260794 iM70 VET 260794-M16507550004 United Kingdom  83.60.260794 iM70 VET 260794-M16507550005 United Kingdom  83.60.260814 iM60 260814-M16506890001 USA  83.60.260814 iM60 260814-M16506890002 USA  83.60.260814 iM60 260814-M16506890003 USA  83.60.260814 iM60 260814-M16506890004 USA  83.60.260814 iM60 260814-M16506890005 USA  83.60.260814 iM60 260814-M16506890006 USA  83.60.260814 iM60 260814-M16506890007 USA  83.60.260814 iM60 260814-M16506890008 USA  83.60.260814 iM60 260814-M16506890009 USA  83.60.260814 iM60 260814-M16506890010 USA  83.60.260814 iM60 260814-M16506890011 USA  83.60.260814 iM60 260814-M16506890012 USA  83.60.260814 iM60 260814-M16506890013 USA  83.60.260814 iM60 260814-M16506890014 USA  83.60.260814 iM60 260814-M16506890015 USA  83.60.260814 iM60 260814-M16509230001 USA  83.60.260814 iM60 260814-M16509230002 USA  83.60.260814 iM60 260814-M16509230003 USA  83.60.260814 iM60 260814-M16509230004 USA  83.60.260814 iM60 260814-M16509230005 USA  83.60.260814 iM60 260814-M16509230006 USA  83.60.260814 iM60 260814-M16509230007 USA  83.60.260814 iM60 260814-M16509230008 USA  83.60.260814 iM60 260814-M16509230009 USA  83.60.260814 iM60 260814-M16509230010 USA  83.60.260814 iM60 260814-M16509230011 USA  83.60.260814 iM60 260814-M16509230012 USA  83.60.260814 iM60 260814-M16509230013 USA  83.60.260814 iM60 260814-M16509230014 USA  83.60.260814 iM60 260814-M16509230015 USA  83.60.260816 iM50 260816-M16506870001 China  83.60.260816 iM50 260816-M16506870002 China  83.60.260823 iM60 260823-M16601840001 New Caledonia  83.60.260827 iM60 260827-M16602490001 India  83.60.260827 iM60 260827-M16602490002 India  83.60.344008 iM60 344008-M16404630001 Portugal  83.60.344008 iM60 344008-M16404630002 Portugal  83.60.344008 iM60 344008-M16404630003 Portugal  83.60.344008 iM60 344008-M16408540001 Portugal  83.60.344008 iM60 344008-M16408540002 Portugal  83.60.344008 iM60 344008-M16408540003 Portugal  83.60.344008 iM60 344008-M16408540004 Portugal  83.60.344009 iM60 344009-K16500160001 Lithuania  83.60.344009 iM60 344009-M16307630001 India  83.60.344009 iM60 344009-M16307630002 India  83.60.344009 iM60 344009-M16307630003 India  83.60.344009 iM60 344009-M16400760001 China  83.60.344009 iM60 344009-M16408490001 Germany  83.60.345010 iM70 345010-M16400790001 China  83.60.345010 iM70 345010-M16500940001 Argentina  83.60.345010 iM70 345010-M16500940002 Argentina  83.60.348002 V-CO2 Module 348002-M16201440003 Ethiopia  83.60.348002 V-CO2 Module 348002-M16201440005 Ethiopia  83.60.348002 V-CO2 Module 348002-M16204980001 India  83.60.348002 V-CO2 Module 348002-M16309110001 Italy  83.60.348002 V-CO2 Module 348002-M16311480001 Macedonia  83.60.348002 V-CO2 Module 348002-M16311710001 Macedonia  83.60.348002 V-CO2 Module 348002-M16311710002 Macedonia  83.60.348002 V-CO2 Module 348002-M16311710003 India  83.60.348002 V-CO2 Module 348002-M16311710004 India  83.60.348002 V-CO2 Module 348002-M16311710005 India  83.60.348002 V-CO2 Module 348002-M16311710006 India  83.60.348002 V-CO2 Module 348002-M16313650001 India  83.60.348002 V-CO2 Module 348002-M16313910001 Malaysia  83.60.348002 V-CO2 Module 348002-M16313910002 Malaysia  83.60.348002 V-CO2 Module 348002-M16313910003 Malaysia  83.60.348002 V-CO2 Module 348002-M16400580001 India  83.60.348002 V-CO2 Module 348002-M16400580002 Macedonia  83.60.348002 V-CO2 Module 348002-M16400580003 India  83.60.360147 iM8 360147-M16304980001 France  83.60.360245 iM70 360245-M16400780001 India",
      "center_classification_date": "20160811",
      "distribution_pattern": "Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Malaysia, Macedonia, Nepal, New Caledonia, Nicaragua, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Sudan, Senegal, Sri Lanka, Thailand, Turkey, United Kingdom, and Uruguay.",
      "state": "CA",
      "product_description": "EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors    EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).",
      "report_date": "20160817",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Edan Diagnostics",
      "recall_number": "Z-2388-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74632",
      "termination_date": "20161116",
      "more_code_info": "",
      "recall_initiation_date": "20160623",
      "postal_code": "92121-4707",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}