{ "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": "Sylmar", "state": "CA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "78093", "recalling_firm": "St Jude Medical Inc.", "address_1": "15900 Valley View Ct", "address_2": "", "postal_code": "91342-3577", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution", "recall_number": "Z-0034-2018", "product_description": "PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.", "product_quantity": "2741 units", "reason_for_recall": "New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.", "recall_initiation_date": "20170828", "center_classification_date": "20171019", "termination_date": "20200708", "report_date": "20171025", "code_info": "Serial Numbers: 2678856 2678867 2678859 2678857 2678877 2678872 2678870 2678869 2683929 2678863 2678858 2678866 2678878 2678868 2678860 2678874 2678879 2678864 2683921 2673458 2683918 2683917 2683914 2683928 2683927 2678862 2683922 2678880 2683920 2683930 2683911 2683916 2675733 2678861 2678871 2683923 2673452 2678876 2675748 2675747 2675742 2675737 2675731 2675743 2673467 2675739 2673449 2673448 2673457 2673459 2673469 2673468 2673466 2673465 2675727 2683924 2678865 2675734 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