{
  "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": "Clamart Cedex",
      "state": "",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80636",
      "recalling_firm": "Sorin CRM SAS",
      "address_1": "Cvk",
      "address_2": "4, avenue Reaumur",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS",
      "recall_number": "Z-2824-2018",
      "product_description": "Sorin Platinium CRT-D 1711 DF-1, Sterile EO.  Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator",
      "product_quantity": "16",
      "reason_for_recall": "Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.",
      "recall_initiation_date": "20180709",
      "center_classification_date": "20180815",
      "termination_date": "20240906",
      "report_date": "20180822",
      "code_info": "Model TDF033U, UDI GTIN 08031527015538      Serial Numbers: 619DK0FB,  618DK003,  619DK0C0,  622DK03B,  622DK12A,  624DK070,  624DK12F,  619DK021,  627DK0B0,  618DK0A4,  619DK097,  620DK065,  619DK09B,  619DK05F,  619DK088,  619DK0CC",
      "more_code_info": ""
    }
  ]
}