{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86544",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "address_2": "N/A",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.",
      "recall_number": "Z-0306-2021",
      "product_description": "Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.",
      "product_quantity": "64 devices",
      "reason_for_recall": "There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.",
      "recall_initiation_date": "20200921",
      "center_classification_date": "20201029",
      "termination_date": "20221228",
      "report_date": "20201104",
      "code_info": "Model 5995000-5; Lot/Serial Numbers as below:    REVVX1800093CN  REVVX1700044CN  REVVX1900040CN  REVVX2000001CN  REV2A1900002CN  REV2A2000014CN  REVVX2000031CN  REV2A2000013CN  REVVX1600023CN  REVVX1800015CN  REVVX1900092CN  REV2A2000006CN  REVVX1900003CN  REV2A2000003CN  REV2A2000015CN  REV2A1900003CN  REVVX1800061CN  REV2A2000007CN  REVVX1700078CN  REVVX1900071CN  REVVX1900006CN  REVVX1900003CN  REVVX1800124CN  REVVX1800030CN  441066CN8  00000436942CN7  REV2A2000010CN  00000442968CN4  REVVX1900049CN  00000439505CN9  REVVX1700064CN  00000440315CN0  REV2A2000017CN  DUMFMI25490001  REV2A2000001CN  00000442412CN3  REV2A2000002CN  REVVX1700054CN  REVVX1800100CN  REV2A2000012CN  REVVX1800040CN  REVVX1600046CN  REV2A2000016CN  REGGL2000003YC  REVVX1900013CN  REVVX1600030CN  REV2A1900001CN  REVVX1700117CN  REVVX1800083CN  REVVX1700106CN  00000440441CN4  REV2A2000018CN  REV2A1900005CN  REV2A2000009CN  00000438438CN4  REVVX1900102CN  REV2A2000011CN  REV2A2000004CN  DUMFMI25490005    4 included units with lot/serials not available."
    }
  ]
}