{
  "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": "Stockholm",
      "state": "N/A",
      "country": "Sweden",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87797",
      "recalling_firm": "RAYSEARCH LABORATORIES AB",
      "address_1": "Sveavagen 9",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1597-2021",
      "product_description": "RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B\tincluding some of the Service Packs. Standalone software treatment planning system",
      "product_quantity": "116 units",
      "reason_for_recall": "For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the  Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as \u0018Clinical\u0019, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled \u0018Approximate: Mixed dose\u0019. The difference between approximate and final \u0018Clinical\u0019 dose is in most cases small, but there can be body sites such as lung where the difference can be significant.",
      "recall_initiation_date": "20210222",
      "center_classification_date": "20210514",
      "termination_date": "20230501",
      "report_date": "20210526",
      "code_info": "Build number:   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  or  10.1.0.613    UDI:  RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35) N/A  RayStation 5 Service Pack 3 (5.0.3.17)  UDI 07350002010020  RayStation 6/RayPlan 2 (6.0.0.24) UDI 07350002010013  RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) UDI 07350002010082  RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7)  UDI 07350002010075  RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6)  UDI 07350002010242  RayStation/RayPlan 7 (7.0.0.19)  UDI 07350002010068  RayStation/RayPlan 8A (8.0.0.61) UDI 07350002010112  RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) UDI 07350002010136  RayStation/RayPlan 8B (8.1.0.47) UDI 07350002010129  RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) UDI 07350002010204  RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) UDI  07350002010235  RayStation/RayPlan 9A (9.0.0.113) UDI 07350002010174  RayStation/RayPlan 9B (9.1.0.933) UDI 07350002010266  RayStation/RayPlan 9B Service Pack 1 (9.2.0.483) UDI 07350002010297  RayStation/RayPlan 10A (10.0.0.1154) UDI  07350002010303  RayStation/RayPlan 10A Service Pack 1 (10.0.1.52) UDI 07350002010365  RayStation/RayPlan 10B (10.1.0.613) UDI 07350002010310"
    }
  ]
}