{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80308",
      "recalling_firm": "Medtronic Navigation, Inc.",
      "address_1": "826 Coal Creek Cir",
      "address_2": "",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: MN, NY, PA, FL, AZ, MA, VA, CA, CO, AL, WI, TX, MO, DC, OH, NH, GA, SC, NJ, WA, CT, MI, OK, IN, MD, IL, KY, LA, OR, RI, UT, AR, MS, TN, NC    Foreign: United Kingdom, Germany, Switzerland, Netherlands, Israel",
      "recall_number": "Z-3251-2018",
      "product_description": "Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542",
      "product_quantity": "161",
      "reason_for_recall": "Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.",
      "recall_initiation_date": "20180601",
      "center_classification_date": "20180926",
      "termination_date": "20220202",
      "report_date": "20181003",
      "code_info": "UDI #: 00643169655935, 00643169792890, 00643169905719,  Serial #:071217-001  110317-001  110603.001  110720.01  110825.01  111103.01  120601-001  120711.01  120920.01  130507.01  130523.01  130703.01  132078  132084  132160  132189  132190  132230  142071  142286  142310  142351  142352  142769  142815  142858  150175  151308  151329  151394  151460  151597  151697  2UA9160WND  50610.001  80414.001  81215.001  90112.001  90515.01  90519.02  CCS40011  N06183105  N06187582  N06201398  N06201536  N06203635  N06205585  N06207497  N06208756  N06210356  N06211047  N06211282  N06218634  N06228349  N06233025  N06237425  N06241803  N06241804  N06241913  N06242904  N06245890  N06251476  N06253719  N06253740  N06259079  N06262594  N06263649  N06265357  N06267972  N06267973  N06267974  N06269032  N06269438  N06269439  N06270019  N06278606  N06278607  N06278608  N06278609  N06279636  N06289894  N06289895  N06289896  N06289897  N06303708  N06303710  N06303711  N06319401  N06319402  N06319403  N06319404  N06320401  N06320795  N06502349  N06502350  N06503495  N06503496  N06671901  N06671902  N06676031  N06676032  N06676033  N06685201  N06685202  N06685203  N06685204  N06685206  N06687250  N06687251  N06687252  N06687253  N06687254  N06688835  N06734368  N06734369  N06740305  N06757275  N06763190  N06764462  N06767959  N06768840  N06772396  N06774642  N06774643  N06774644  N06777604  N06781010  N06805982  N06805983  N06807016  N06807017  N06807018  N06807019  N07279689  N07279690  N07279692  N07279693  N07291034  N07291035  N07291036  N07291037  N07291038  N07300434  N07372598  N07385291  N07385292  N07389258  N07389259  N07389260  N07582374  N07582375  N07816044  N07816045  N07816046  N07400747  N07400744  100811-001  N07400746  N07400745",
      "more_code_info": ""
    }
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}