{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Franklin",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79453",
      "recalling_firm": "Heidelberg Engineering",
      "address_1": "10 Forge Pkwy",
      "address_2": "N/A",
      "postal_code": "02038-3137",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationally",
      "recall_number": "Z-1535-2018",
      "product_description": "Widefield OCT software feature for the Spectralis HRA+OCT and variants",
      "product_quantity": "382",
      "reason_for_recall": "FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineering submitted a new 510(k) for this feature.   FDA has asked Heidelberg Engineering to instruct customers not to use the Widefield OCT software feature on the SPECTRALIS device until 510(k) clearance has been obtained for this software feature.",
      "recall_initiation_date": "20171208",
      "center_classification_date": "20180426",
      "termination_date": "20200604",
      "report_date": "20180502",
      "code_info": "The Widefield OCT software feature was made available on the SPECTRALIS Software US versions 6.3 to 6.8a  It is only usable with the  Widefield Objective Module  accessory and a dedicated license."
    }
  ]
}