{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "103953",
      "product_res_number": "Z-0037-2012",
      "event_date_initiated": "2011-08-12",
      "event_date_posted": "2011-10-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-11-06",
      "res_event_number": "59898",
      "product_code": "LWS",
      "pma_numbers": [
        "P910077"
      ],
      "product_description": "LATITUDE Paceart Integration Software, version 1.00 Model 6472.\n\nLATITUDE Paceart Integration is software and therefore does not have any serial numbers.  However, the software version affected is version 1.00 and is distributed on USB pen drives.  These pen drives are lot number controlled and denoted as Model 6493.\n\nWhen used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.",
      "code_info": "software verson 1.00",
      "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": "Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software\nmay not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.",
      "root_cause_description": "Software design",
      "action": "Consignees were sent on 8/12/11 a Boston Scientific letter dated August 2011. The letter was addressed to \"Dear Doctor\". The letter described the product and problem.  It also gave Background Information, Description of Potential Data Translation Error, and Additional Information and Action information.\n\nA letter, including an HRS form, was also sent to all US LATITUDE Clinics that have active LPI software to notify them of the need to install the corrected LPI Software.",
      "product_quantity": "398",
      "distribution_pattern": "Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT DE, DC, FL, GA, IL,IN, IA, KS, KY, LA,ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OJ, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA,WV, WI, and WY.",
      "openfda": {
        "pma_number": [
          "P920015",
          "P030035",
          "P930035",
          "P110042",
          "P980016",
          "P970024",
          "P940024",
          "P890061",
          "P910073",
          "P910023",
          "P980050",
          "P880086",
          "P880006",
          "P010012",
          "P830060",
          "P220012",
          "P010031",
          "P980023",
          "P050023",
          "P940008",
          "P980049",
          "P950022",
          "P030054",
          "P900061",
          "P910077",
          "P970013",
          "P960040"
        ],
        "registration_number": [
          "1828132",
          "3014461810",
          "3003120897",
          "3002807314",
          "1225687",
          "3005334138",
          "3008988055",
          "9616693",
          "3018094310",
          "2022502",
          "2011171",
          "2032521",
          "2133641",
          "1000121056",
          "2135338",
          "3010273872",
          "2124215",
          "3033257494",
          "1000165971",
          "3002806603",
          "3004961578",
          "3009380063",
          "1423662",
          "3013674629",
          "3010288227",
          "3008159616",
          "3015453963",
          "2030624",
          "3004105270",
          "3003276151",
          "3006705815",
          "3013596024",
          "2183744",
          "3015544746",
          "2649622",
          "2183787",
          "2182208",
          "9610139",
          "3013500228",
          "3003932293",
          "2648729",
          "3004593495",
          "2017865",
          "3008494315",
          "3008973940",
          "3002807561",
          "3013288201",
          "3011120183",
          "9614453",
          "3012552532",
          "1028232",
          "3004209178"
        ],
        "fei_number": [
          "1828132",
          "3014461810",
          "3003120897",
          "3002807314",
          "3005334138",
          "3008988055",
          "3018094310",
          "2022502",
          "2011171",
          "1000121056",
          "3010273872",
          "2124215",
          "3033257494",
          "1000165971",
          "3005700659",
          "3003574398",
          "3002806603",
          "3004961578",
          "3009380063",
          "3002807576",
          "3013674629",
          "3010288227",
          "3008159616",
          "3015453963",
          "3004105270",
          "3004369318",
          "3003276151",
          "3006705815",
          "3000215273",
          "3013596024",
          "2183744",
          "3015544746",
          "2649622",
          "2183787",
          "2182208",
          "3008377825",
          "3002806500",
          "3013500228",
          "3003932293",
          "2648729",
          "3004593495",
          "2017865",
          "3008973940",
          "3002807561",
          "3002618605",
          "3011120183",
          "3013288201",
          "3000203466",
          "3000206435",
          "3001451463",
          "3012552532",
          "1028232"
        ],
        "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}