{
  "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": "London",
      "state": "",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74607",
      "recalling_firm": "Vision RT Ltd",
      "address_1": "Dove House, Arcadia Avenue",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Product distributed in US.    The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom.    No product was distributed to US government accounts.",
      "recall_number": "Z-2668-2016",
      "product_description": "TrueBeam¿ Radiotherapy Delivery System and EDGE\" Radiotherapy Delivery System, K140528.  The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.",
      "product_quantity": "47",
      "reason_for_recall": "Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS].  1. CRM 3194, No Serious Injury, No MDR, Aware date:  Dec 11, 2015    2. CRM 3321, No Patient Involved, No MDR, Aware date:  Jan 19, 2016  3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016\t  No patient harm was reported in any of these cases.",
      "recall_initiation_date": "20160630",
      "center_classification_date": "20160825",
      "termination_date": "20170920",
      "report_date": "20160831",
      "code_info": "Serial Number of the device(s) distributed  248-016  248-021  248-022  248-030  248-038  248-041  248-063  248-064  249-1514  249-1516  248-071  249-0239  248-073  248-080  248-084  249-0043  249-0055  249-0056  249-0058  249-0069  249-0130  249-0137  249-1509  249-0141  249-0275  249-0152  249-0162  249-0169  249-0251  249-0253  249-0254  249-0288  249-1503  249-1512  249-1518  249-TBD  249-0061  249-0131  249-0256  249-0289  249-0290  249-TBD  248-083  249-0273  249-0276  249-1500  249-1519",
      "more_code_info": ""
    }
  ]
}