{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104862", "product_res_number": "Z-0333-2012", "event_date_initiated": "2011-10-12", "event_date_posted": "2011-12-01", "recall_status": "Terminated", "event_date_terminated": "2012-12-04", "res_event_number": "60244", "product_code": "LWS", "pma_numbers": [ "P910077" ], "product_description": "LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA).\n\nThere are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US\n\nThe LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1.\n\nBoth the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements.", "code_info": "Models 6441*, 6442*, 6465*, 6488 (USA).", "firm_fei_number": "2124215", "recalling_firm": "Boston Scientific CRM Corp", "address_1": "4100 Hamline Ave N", "city": "Saint Paul", "state": "MN", "postal_code": "55112-5700", "additional_info_contact": "651-582-4000", "reason_for_recall": "Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LATITUDE (if activated). However, the mea", "root_cause_description": "Software design", "action": "Boston Scientific sent an \"IMPORTANT DIAGNOSTIC INFORMATION\" letter dated October 2011 to all affected customers. The letter described the product, problem and actions to be taken by the customers.", "product_quantity": "25,300 (14,700 US; 10,600 OUS)", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, CANADA, AUSTRALIA, NEW ZEALAND, CYPRUS, CZECH REPUBLIC, GREECE, GUADELOUPE, HUNGARY, BANGLADESH, CHINA, COCOS ISLAND, HONG KONG, INDIA, INDONESIA, KOREA, MALAYSIA, PHILIPPINES, SINGAPORE, SOUTH KOREA, SRI LANKA, THAILAND, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, NEW CALEDONIA, POLAND, PORTUGAL, QATAR, REUNION,IRAN, ISRAEL, JORDAN, KUWAIT, LATVIA, LEBANON, LUXEMBOURG, MONACO, MOROCCO, JAPAN, ARGENTINA, ARUBA, BAHAMAS, BARBADOS, BELIZE, BERMUDA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, FALKLAND ISLANDS, HAITI, HONDURAS, JAMAICA, MEXICO, PANAMA, PERU, TRINIDAD & Tobago, URUGUAY, VENEZUELA, AND NETHERLANDS ANTILLES.", "openfda": { "pma_number": [ "P980050", "P970013", "P910023", "P220012", "P910073", "P940008", "P940024", "P890061", "P010012", "P930035", "P050023", "P880086", "P110042", "P980023", "P010031", "P900061", "P880006", "P950022", "P910077", "P030035", "P980016", "P980049", "P830060", "P920015", "P970024", "P030054", "P960040" ], "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3004593495", "3008159616", "2022502", "1000121056", "9610139", "2032521", "3005334138", "2030624", "3004961578", "3003932293", "2017865", "3015453963", "1225687", "3013500228", "3018094310", "2649622", "3002807314", "1828132", "3003276151", "2183744", "3008494315", "3003120897", "1028232", "3009380063", "3008988055", "3010273872", "3011120183", "1000165971", "3008973940", "1423662", "2133641", "3004209178", "2011171", "3013288201", "2183787", "3013674629", "3002807561", "3014461810", "2182208", "3006705815", "9616693", "3004105270", "2124215", "3015544746", "2135338", "3033257494", "3013596024", "9614453", "2648729", "3012552532", "3002806603", "3010288227" ], "fei_number": [ "3004593495", "3008159616", "2022502", "1000121056", "3004369318", "3005334138", "3004961578", "2017865", "3003932293", "3015453963", "3013500228", "3018094310", "2649622", "3002807314", "3001451463", "1828132", "3003276151", "2183744", "3003120897", "1028232", "3002807576", "3009380063", "3008988055", "3010273872", "3003574398", "3011120183", "1000165971", "3008973940", "3000215273", "3000203466", "2011171", "3013288201", "2183787", "3013674629", "3002807561", "3014461810", "2182208", "3006705815", "3005700659", "3004105270", "3002618605", "2124215", "3015544746", "3002806500", "3013596024", "3000206435", "3033257494", "3008377825", "2648729", "3012552532", "3002806603", "3010288227" ] } } ] }