{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Saluggia, VC",
      "state": "",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "67013",
      "recalling_firm": "Sorin Group Italia S.r.l.",
      "address_1": "Via Crescentino",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "Z-0805-2014",
      "product_description": "ORCHESTRA/ORCHESTRA PLUS Programmer",
      "product_quantity": "1,718",
      "reason_for_recall": "Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.",
      "recall_initiation_date": "20131120",
      "center_classification_date": "20140122",
      "termination_date": "20140908",
      "report_date": "20140129",
      "code_info": "ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models.  - REPLY Models D, DR, VDR, SR  - ESPRIT Models D, DR, S, SR  - FACIL Model DR1",
      "more_code_info": ""
    }
  ]
}