{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "106088",
      "product_res_number": "Z-0638-2012",
      "event_date_initiated": "2011-11-14",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-06-26",
      "res_event_number": "60631",
      "product_code": "HJB",
      "product_description": "Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number:  Octopus 900, Distributed by:  Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH  45040 \n\nProduct Usage:  The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.",
      "code_info": "Model Number:  Octopus 900, S/N's: 159, 231, 279, 313, 314, 315, 336, 338, 478, 479, 484, 485, 559, 560,561, 562, 563, 642, 644, 645, 646, 647, 648, 649, 650, 651, 772, 773, 774, 775, 776, 777, 797, 798, 804, 805, 806, 807, 808, 813, 814, 839, 840, 841, 842, 843, 844, 868, 869, 870, 871, 872, 873, 874, 903, 904, 905, 907, 908, 909, 910, 911, 956, 957, 958, 959, 975, 983, 984, 985, 986, 987, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1034, 1035, 1036, 1037, 1038, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1117, 1118, 1119, 1120, 1140, 1141, 1143, 1152, 1162, 1163, 1164, 1166, 1199, 1200, 1201, 1202, 1239, 1240, 1241, 1262, 1263, 1286, 1287, 1288, 1307, 1308, 1401, 1402, 1403, 1404, 1405, 1424, 1425, 1426, 1458, 1459, 1460, 1480, 1481, 1482, 1483, 1484, 1543, 1545, 1546, 1550, 1552, 1553, 1554, 1555, 1556, 1560, 1561, 1562, 1563, 1564, 1579, 1580, 1581, 1582, 1583, 1586, 1587, 1588, 1589 and 1591.",
      "firm_fei_number": "1000136533",
      "recalling_firm": "Haag-Streit USA Inc",
      "address_1": "3535 Kings Mills Rd",
      "city": "Mason",
      "state": "OH",
      "postal_code": "45040",
      "additional_info_contact": "Russell F. Wolfe\n513-398-3937 Ext. 1167",
      "reason_for_recall": "Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on.   If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.",
      "root_cause_description": "Software design",
      "action": "Haag-Streit USA Inc sent an Urgent Field Safety Notice letter dated November 11, 2011 to their customers.  The letter identified the product, the problem, and the actions to be taken.  Customers were instructed to check their unit and if needed upgrade their unit with the new software provided.  Customers were advised to complete and return the Software Update Verification Form included.  Customers who had distributed the affected product outside of their facility were instructed to immediately notify their customers of the recall.",
      "product_quantity": "158 Units",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the states of:  AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA and WA and the country of Mexico.",
      "openfda": {
        "k_number": [
          "K852424",
          "K924779",
          "K864037",
          "K864369",
          "K930444"
        ],
        "registration_number": [
          "1045379",
          "8040382",
          "8040381",
          "3013503739",
          "8040278",
          "3004571672",
          "9614661",
          "3008729548",
          "9612297",
          "1646747",
          "1836161",
          "8043368",
          "3010041511",
          "3009465247",
          "3011137372",
          "2529846",
          "3011898560",
          "3008618183",
          "3003951061"
        ],
        "fei_number": [
          "1000194896",
          "1045379",
          "3002809378",
          "6749",
          "3005747797",
          "3002750084",
          "3004571672",
          "1000160162",
          "1000175127",
          "3008729548",
          "3003951061",
          "1000136191",
          "6750",
          "3010041511",
          "3009465247",
          "3004216008",
          "3011898560",
          "3008618183",
          "3013503739"
        ],
        "device_name": "Instrument, Measuring, Corneal Radius",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1450",
        "device_class": "1"
      }
    }
  ]
}