{
  "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": "143138",
      "product_res_number": "Z-0904-2016",
      "event_date_initiated": "2016-01-20",
      "event_date_created": "2016-02-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-10-13",
      "res_event_number": "73088",
      "product_code": "GCQ",
      "product_description": "Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope",
      "code_info": "Serial Numbers: 2407409,2407584,2306291,2204284,2305898,2406901,2306874,2000549,2203971, 2407393,2203790,2000405,2306456,2102668,2203672,2406988,2102128,2103100, 2103035,2204108,2204527,2000464,2204116,2102323,2417865,2102954,2519556, 2418512,2306371,2305350,2407684,2519174,2519207,2519210,2102734,2205217, 2001322,2418634,2406987,2418156,2305446,2204190,2204202,2103307,2101785, 2518969,2519343,2102896,2203946,2001430,2305568,2102316,2305870,2204258",
      "firm_fei_number": "3010663403",
      "recalling_firm": "Integrated Medical Systems Inc",
      "address_1": "3200 2nd Ave N",
      "city": "Birmingham",
      "state": "AL",
      "postal_code": "35222-1212",
      "additional_info_contact": "Ms. Kathryn E. Cadorette \n205-244-1743",
      "reason_for_recall": "If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The firm notified their consignees of the issue by Fed Ex on 01/20/2016.  The firm plans to coordinate with the medical facilities for inspection of the endoscopes.",
      "product_quantity": "54 instruments",
      "distribution_pattern": "Distributed US (nationwide) and in Australia.",
      "openfda": {
        "device_name": "Endoscope, Flexible",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "3013445147",
          "2032521",
          "3009756153"
        ],
        "fei_number": [
          "3013445147",
          "3003574398",
          "3009756153"
        ],
        "k_number": [
          "K860771",
          "K900894",
          "K864960",
          "K871978",
          "K920979"
        ]
      }
    }
  ]
}