{
  "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: 37 units, Foreign: 269 units",
      "code_info": "Equipment ID Numbers for US units:  54842754, 54841669, 54842420, 85013694, 54842411, 54840875, 54841972, 54841973, 85017625, 85017625, 58000559, 85013233, 6482124, 54841111, 54842348, 54842197, 54842276, 52412604, 47441885, 85013624, 85013511, 85013710, 85012718, 54842406, 54843508, 5241714; -- 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 V4;  Image Suite V4: DICOM STORE SCP:  REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop:  REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered  System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer:  Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. 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-1594-2016",
      "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"
    }
  ]
}