RayStation 9B SP1Recalls & reported problems

Summary

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

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

8 other recalls cover devices cleared under the same FDA submission (K200569); 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. 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-1187-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. Mar 28, 2024Open, Classified

   Potential for reported SSD to be too high.

   Z-1745-2024 · Root cause: Software design · FDA record ↗

3. 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 ↗

4. 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 ↗

5. Dec 30, 2021Open, Classified

   If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

   Z-0732-2022 · Root cause: Software design · 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 ↗

11. 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-2351-2020 · Root cause: Software design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200569. One submission often covers many models, so check the product and lot details in each record.

• Z-2489-2025 · Aug 8, 2025 · Open, Classified
  RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 1
• Z-1746-2024 · Mar 28, 2024 · Open, Classified
  RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System.
• Z-1403-2022 · Jun 1, 2022 · Terminated
  RayStation 9B SP1. For radiation treatment planning.
• Z-1838-2021 · Apr 21, 2021 · Terminated
  RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 ,
• Z-1598-2021 · Apr 7, 2021 · Terminated
  RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
• Z-1427-2021 · Mar 25, 2021 · Open, Classified
  RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
• Z-0589-2021 · Nov 11, 2020 · Terminated
  RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10
• Z-0478-2021 · Oct 8, 2020 · Terminated
  RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a