{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "124518",
      "product_res_number": "Z-0805-2014",
      "event_date_initiated": "2013-11-20",
      "event_date_posted": "2014-01-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-09-08",
      "res_event_number": "67013",
      "product_code": "LNX",
      "pma_numbers": [
        "P950029S041",
        "P980049S050",
        "P060027S011",
        "P980049S006"
      ],
      "product_description": "ORCHESTRA/ORCHESTRA PLUS Programmer",
      "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",
      "firm_fei_number": "1000165971",
      "recalling_firm": "Sorin Group Italia S.r.l.",
      "address_1": "Via Crescentino",
      "city": "Saluggia VC",
      "country": "Italy",
      "additional_info_contact": "Steve Smith\n303-467-6222",
      "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.",
      "root_cause_description": "Software design",
      "action": "On Nov 20 and Nov 25, 2013, the Dear Doctor\nLetter was sent by certified mail to 1,310 physicians who are following 13,003 patients\nimplanted with a REPLU or ESPRIT pacemakers in the US. Sorin provided the following recommendations to the physicians:\n You should consider checking the battery impedance of the last follow-up exam. In case\nthe battery impedance is greater than or equal to 3.5k, a follow-up visit must be\nscheduled within a maximum of 6 months from the last follow-up visit.\n When pacemaker operation is checked by the simple application of a magnet, a magnet\nrate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre.\n As a general rule, a maximum of 6 month follow-up interval when the battery impedance\nbecomes greater than or equal to 3.5 k. This recommendation should also be followed\nsubsequent to the installation of the new programmer software version.",
      "product_quantity": "1,718",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "k_number": [
          "K921846"
        ]
      }
    }
  ]
}