{
  "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": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87569",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "address_2": "N/A",
      "postal_code": "55432-3568",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom.",
      "recall_number": "Z-1368-2021",
      "product_description": "A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and  3.0.1057*  * Version 3.0.1057 is approved for distribution in Europe only.",
      "product_quantity": "5332 downloads",
      "reason_for_recall": "There are two issues within this correction action:  1. Cycling Issue:  When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the \"replacement\" function of the A610 clinician programmer application, the cycling feature is not copied properly.  2. Log Fill Issue:  When the Percept PC INS System Event log is full, the  clinician programmer A610 Software application version  2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.",
      "recall_initiation_date": "20210309",
      "center_classification_date": "20210407",
      "report_date": "20210414",
      "code_info": "version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057*  * Version 3.0.1057 is approved for distribution in Europe only."
    }
  ]
}