{
  "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": "Ongoing",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89822",
      "recalling_firm": "RaySearch America Inc",
      "address_1": "350 5th Ave Ste 5000",
      "address_2": "The Empire State Building",
      "postal_code": "10118-0110",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI.",
      "recall_number": "Z-0850-2022",
      "product_description": "RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs:  RayStation 4.0 (4.0.0.14) to   RayStation 5 Service Pack 2 (5.0.2.35),   RayStation 5 Service Pack 3 (5.0.3.17),   RayStation 6/RayPlan 2 (6.0.0.24),   RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2),   RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7),   RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6),   RayStation/RayPlan 7 (7.0.0.19),   RayStation/RayPlan 8A (8.0.0.61),   RayStation/RayPlan 8A Service Pack 1 (8.0.1.10)     Software versions: 4.0.0.14, 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116 or 12.0.0.932",
      "product_quantity": "653 (US 149, OUS 504)",
      "reason_for_recall": "Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.",
      "recall_initiation_date": "20220211",
      "center_classification_date": "20220331",
      "report_date": "20220406",
      "code_info": "UDI # 07350002010020,   07350002010013, 07350002010082, 07350002010075, 07350002010242, 07350002010068, 07350002010112, 07350002010136, 07350002010129, 07350002010204, 07350002010235, 07350002010174, 07350002010266, 07350002010297, 07350002010303, 07350002010365, 07350002010310, 07350002010471, 07350002010389, 07350002010433, 07350002010440, 07350002010426"
    }
  ]
}