RayStation 10.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350002010310), received between Mar 2, 2023 and Mar 2, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

10 FDA recall records name this device's identifier, 6 still open.

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. Nov 28, 2025Open, Classified

   Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

   Z-1102-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Jan 16, 2025Open, Classified

   Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

   Z-1188-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. Mar 28, 2024Open, Classified

   Potential for reported SSD to be too high.

   Z-1747-2024 · Root cause: Software design · FDA record ↗

4. 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 ↗

5. 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 ↗

6. 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 ↗

7. 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 ↗

8. Jun 8, 2021Terminated

   Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.

   Z-2138-2021 · Root cause: Under Investigation by firm · FDA record ↗

9. 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 ↗

10. 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 ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2023Computer Software Problem; Computer Software Problem

  NO EVENT OCCURRED. NO PATIENTS WERE AFFECTED. THERE IS ONLY A POTENTIAL HEALTH HAZARD DISCOVERED BY THE MANUFACTURER. THIS ISSUE CONCERNS THE VOXELWISE WORST CLINICAL GOALS IN THE ROBUST EVALUATION MODULE OF RAYSTATION 8B, 9A, 9B, 10A AND 10B. EVALUATION OF A CLINICAL GOAL FOR THE VOXELWISE WORST DOSE DISTRIBUTIONS MAY BE MISLEADING AFTER EDITING THE CLINICAL GOAL. AN ADDITIONAL ISSUE WAS FOUND UN THE CONTOURING WHEN THE SPACING BETWEEN SLICES IS LESS THAN OR EQUAL TO 1 MM, PRESENT IN RAYSTATION/RAYPLAN VERSIONS FROM 6 UP TO 10A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468458 ↗