{
  "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": [
    {
      "status": "Terminated",
      "city": "Saluggia, VC",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77983",
      "recalling_firm": "Sorin Group Italia SRL - CRF",
      "address_1": "Via Crescentino",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-3230-2017",
      "product_description": "Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator,   Biventricular or ventricular antitachycardia pacing,   Dual or single chamber arrhythmia detection    Product  Usage:  PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).",
      "product_quantity": "154 units",
      "reason_for_recall": "There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.",
      "recall_initiation_date": "20170724",
      "center_classification_date": "20170927",
      "termination_date": "20240129",
      "report_date": "20171004",
      "code_info": "All Serial Numbers"
    }
  ]
}