RayStation 8.1Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

8 FDA recall records name this device's identifier, 3 still open.

29 other recalls cover devices cleared under the same FDA submission (K190387); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 23, 2024Open, Classified

   A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.

   Z-1482-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Feb 11, 2022Open, Classified

   Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

   Z-0850-2022 · Root cause: Under Investigation by firm · FDA record ↗

3. Sep 22, 2021Open, Classified

   An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated

   Z-0849-2022 · Root cause: Device Design · FDA record ↗

4. Sep 9, 2021Terminated

   If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning

   Z-0848-2022 · Root cause: Under Investigation by firm · FDA record ↗

5. Feb 22, 2021Terminated

   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 Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

   Z-1597-2021 · Root cause: Software design · FDA record ↗

6. Jan 22, 2021Terminated

   A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose statistics for an incorrectly created ROI are used to determine if a plan is acceptable for treatment, this could potentially lead to an inappropriate plan being approved. The error could lead to a more conservative or more liberal plan than intended.

   Z-2039-2023 · Root cause: Software design · FDA record ↗

7. May 18, 2020Terminated

   Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

   Z-2346-2020 · Root cause: Software design · FDA record ↗

8. Feb 20, 2020Terminated

   There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.

   Z-1464-2020 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190387. One submission often covers many models, so check the product and lot details in each record.

• Z-2488-2025 · Aug 8, 2025 · Open, Classified
  RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B S
• Z-1186-2025 · Jan 16, 2025 · Open, Classified
  Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RaySta
• Z-1743-2024 · Mar 28, 2024 · Open, Classified
  RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
• Z-1744-2024 · Mar 28, 2024 · Open, Classified
  RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
• Z-1281-2023 · Feb 17, 2023 · Open, Classified
  Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0
• Z-2426-2020 · May 26, 2020 · Open, Classified
  RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
• Z-2353-2020 · May 18, 2020 · Terminated
  RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2350-2020 · May 18, 2020 · Terminated
  RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2344-2020 · May 18, 2020 · Terminated
  RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2342-2020 · May 18, 2020 · Terminated
  RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2347-2020 · May 18, 2020 · Terminated
  RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2349-2020 · May 18, 2020 · Terminated
  RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2343-2020 · May 18, 2020 · Terminated
  RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2340-2020 · May 18, 2020 · Terminated
  RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
• Z-2348-2020 · May 18, 2020 · Terminated
  RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

…and 14 more.