{
  "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": "2026-08-22",
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      "product_res_number": "Z-0826-2022",
      "event_date_initiated": "2022-01-11",
      "event_date_created": "2022-03-25",
      "recall_status": "Terminated",
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      "res_event_number": "89715",
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      "code_info": "Software Version 4.7.2",
      "firm_fei_number": "3009422347",
      "recalling_firm": "Diagnos Inc",
      "address_1": "7005 Taschereau Blvd Suite 265 7005 Taschereau Blvd",
      "address_2": "Suite 265",
      "city": "Brossard",
      "country": "Canada",
      "reason_for_recall": "Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.",
      "root_cause_description": "No Marketing Application",
      "action": "On 01/11/22, a recall notice was emailed to the firm's customer who was informed to immediately cease using the affected software.  The only version of software cleared for commercialization is CARA v1.2.1.  The customer was asked to contact a quality management representative if they had questions or comments at 1-405-678-8882 ext. 235 or mmassue@diagnos.ca",
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        "medical_specialty_description": "Radiology",
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