{
  "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": "IMOLA, BO",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65036",
      "recalling_firm": "CEFLA DENTAL GROUP",
      "address_1": "VIA BICOCCA 14/C",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FOREIGN:  CANADA; DOMESTIC:  GA, TX, IL, CA, FL, NY, MA, AL, NJ, SC, WA, LA, MD, WY, CT, NM, WI, CO, NC, VA, PA and MI.",
      "recall_number": "Z-1217-2013",
      "product_description": "MyRay RXDC dental unit     x-ray unit",
      "product_quantity": "173 shipped to US",
      "reason_for_recall": "The RX DC dental x-ray unit was found to be noncompliant with  21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically,   1. The tube housing did not contain a Certification label.  2. The collimator did not contain an identification label.  3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at ma",
      "recall_initiation_date": "20120810",
      "center_classification_date": "20130523",
      "termination_date": "20150304",
      "report_date": "20130529",
      "code_info": "Model -  MyRay  RX DC"
    }
  ]
}