{
  "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": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "150 Verona St",
      "reason_for_recall": "Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as \"L (Left)\", when it should be \"R(Right)\".",
      "address_2": "",
      "product_quantity": "US: 50 units; Foreign: 2499 units",
      "code_info": "Equipment ID Numbers: US units: 8501-2596, 85018860, 8501-0954, 5241-2596,  5241-2546, 5241-2713, 5296-3447, 52414419, 52414455, 5241-2640, 5241-2716, 54838552, 5483-8502, 8501-4665, 52408158, 85014687, 54839128,  5483-9212, 52412539, 52414661, 52962897, 4745-3986, 5241-2337, 85012262, 8501-5898, 8501-2602, 54838630, 52412670, 5296-3450, 5296-3449, 54838554, 52408157, 54838618, 5241-4547, 54842652, 52420675, 8501-2861,   52414685, 52414751, 5484-3086, 54838598, 52412367, 52414417, 54839211, 54838616, 4745-5991, 52412243, 54842667, 52417149, 52412340; -- Equipment ID Numbers for Foreign Units:  Please contact CDRH Recall Group for list of affected Equipment ID Numbers.",
      "center_classification_date": "20160502",
      "distribution_pattern": "NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, Brazil, Bulgaria, Cambodia, Canada, Chad, Chile, China, Colombia, Croatia, Czech Rep., Djibouti, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Liechtenstein, Lithuania, Macao, Malaysia, Mexico, Montenegro, Myanmar (Burma), Nepal, Netherlands, New Zealand, Niger, Norway, Oman, Peru, Philippines,  Poland, Portugal, Romania, Russia, Saudi Arabia, Scotland, Serbia, Singapore, Slovakia, South Africa, South Korea,  Spain, Sri Lanka, Taiwan, thailand, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam.",
      "state": "NY",
      "product_description": "CARESTREAM Image Suite V3:  MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608  --- CLASSIFICATION NAME: System, Image Processing, Radiological   The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.",
      "report_date": "20160511",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Carestream Health Inc",
      "recall_number": "Z-1593-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73742",
      "termination_date": "20170316",
      "more_code_info": "",
      "recall_initiation_date": "20160415",
      "postal_code": "14608-1733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}