{
  "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": "2026-04-01",
    "results": {
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      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
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      "address_1": "81 Hartwell Ave Ste 300",
      "address_2": "",
      "postal_code": "02421-3160",
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      "distribution_pattern": "US Nationwide distribution in the state of MD.",
      "recall_number": "Z-0918-2021",
      "product_description": "FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage:  intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.",
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      "reason_for_recall": "The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.",
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