{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85271",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "OUS: Japan, Belgium, Denmark, France, Great Britain, and Spain.  No U.S. consignees.",
      "recall_number": "Z-1804-2020",
      "product_description": "iLab Polaris Multi-Modality Guidance System;                     iLab Ultrasound Imaging System",
      "product_quantity": "150 units",
      "reason_for_recall": "Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended.  If either Multi-Frame UltraSound (US)  or SC Image Storage formats are used, the DFR data will not be archived and the user will not be notified of this unexpected behavior.",
      "recall_initiation_date": "20190918",
      "center_classification_date": "20200427",
      "report_date": "20200506",
      "code_info": "Polaris 2.10 software version (disk batch 629774);  iLab Polaris Systems affected product listing (serial numbers):  200204, 200209, 200217, 200308, 200310, 200448, 200450, 200456, 200457, 200458, 200461,200480, 200481, 200103, 200145, 200044, 200118, 200360, 200498, 200170, 8361, 10312, 10443, 10548, 7402, 8397, 8497, 8498, 8508,  8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278,10362, 10365, 10496, 10500, 10565, 10566, 10604, 10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876,  10952, 8475, 7402, 8397, 8497, 8498, 8508,  8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604,  10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873, 10875, 10876, 10952, 8475, 7402, 8397, 8497, 8498, 8508,  8516, 8522, 8523, 8530, 10044, 10053, 10275, 10278, 10362, 10365, 10496, 10500, 10565, 10566, 10604,  10651, 10667, 10694, 10753, 10770, 10867, 10872, 10873,  10875, 10876, 10952, 8475, 6582 , 7023, 7857,  5637, 5716,  6650, 6894, 4031,   5003, 5043, 5060,  5109, 5232,   5239, 5393, 5465, 5651,  5678,   5860,  6193,  6350, 8264, 6819, 6921,  6934, 7332, 7341, 7362, 7733,   7828, 7858, 7933, 7934, 8011,   8155, 8290,    6383,  5182,  5219,   5296, 5398, 8157,   6760, 7723,   10108,  8365,  8367,  10504,  10657, 10501, 4274, 8046,  8048, 5892,  7818, 4773, 5585,  8113, 5165,   4402,  6468,   6319,  5313,  7511,  4952, 5277,  5457,  4116,  5403, 5078,  5664,  5666, 6327,  6733, 6994,  6136, 6206,  6172,  7604, 7602, 7353, 6273, 6993, 4045, 10221, 10261, and 8540."
    }
  ]
}