{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Innsbruck",
      "state": "N/A",
      "country": "Austria",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81683",
      "recalling_firm": "MED-EL Elektromedizinische Gereate, Gmbh",
      "address_1": "Furstenweg 77a",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of  California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.",
      "recall_number": "Z-2136-2019",
      "product_description": "MED EL Cochlear Implant System, Mi1000 MED EL  CONCERTO, sold under the following implant types:      a. Mil000 CONCERTO PIN +FLEX28;      b. Mi1000 CONCERTO +FLEX28;      c. Mi1000 CONCERTO PIN +FLEXsoft;      d. Mil000 CONCERTO +Standard;      e. Mil000 CONCERTO +Medium;      f. Mi1000 CONCERTO PIN +Standard;      g. M11000 CONCERTO +Compressed    Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.",
      "product_quantity": "7 devices",
      "reason_for_recall": "Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.",
      "recall_initiation_date": "20181016",
      "center_classification_date": "20190802",
      "termination_date": "20200522",
      "report_date": "20190814",
      "code_info": "a. Mil000 CONCERTO PIN +FLEX28, Serial Number 510312;      b. Mi1000 CONCERTO +FLEX28, Serial Number 518214;      c. Mi1000 CONCERTO PIN +FLEXsoft, Serial Number 531793;      d. Mil000 CONCERTO +Standard, Serial Number 510079;      e. Mil000 CONCERTO +Medium, Serial Number 532046;      f. Mi1000 CONCERTO PIN +Standard, Serial Number 535616;      g. M11000 CONCERTO +Compressed, Serial Number 538434"
    }
  ]
}