{
  "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": [
    {
      "country": "United States",
      "city": "Waukesha",
      "address_1": "3000 N Grandview Blvd",
      "reason_for_recall": "An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.",
      "address_2": "",
      "product_quantity": "26 (US = 4;OUS = 22)",
      "code_info": "Mfg Lot or Serial # System ID  442706CN8 727398REVO  443227CN4 940898REVO  00000442994CN0 919684REVCT  443069cn0 404616CTR  00000442968CN4 83141966438  443342CN1 905521RCT1  00000444648CN0 82421100836  00000442479CN2 82421190324  00000443071CN6 82421300072  00000443308CN2 82421040370  00000444206CN7 82421160425  00000442792CN8 M5480791  00000443675CN4 410014CT04  00000443869CN3 A51773126  00000442785CN2 REV015  00000443501CN2 REV013  00000442940CN3 850210884  00000443590CN5 850210890  00000442289CN5 NO1031CT01  00000444156CN4 CT444156CN4  00000442748CN0 CT442748CN0  00000443952CN7 R002CT09  00000443540CN0 A201CT03  00000444038CN4 AE1015CT02  00000443409CN8 00145CTS01  00000443994CN9 00095CTS04",
      "center_classification_date": "20160429",
      "distribution_pattern": "Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to  AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.",
      "state": "WI",
      "product_description": "GE, Revolution CT.  The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications",
      "report_date": "20160511",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "GE Medical Systems, LLC",
      "recall_number": "Z-1589-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "73974",
      "termination_date": "20160921",
      "more_code_info": "",
      "recall_initiation_date": "20160420",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}