RayStation 12A SP1Recalls & reported problems

Summary

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

4 FDA recall records name this device's identifier, 4 still open.

2 other recalls cover devices cleared under the same FDA submission (K222312); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1105-2026 · Root cause: Under Investigation by firm · Recall details · 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-1191-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Mar 28, 2024Open, Classified

   Potential for reported SSD to be too high.

   Z-1750-2024 · Root cause: Software design · Recall details · 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 · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K222312. One submission often covers many models, so check the product and lot details in each record.

• Z-2493-2025 · Aug 8, 2025 · Open, Classified
  RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStat
• Z-1751-2024 · Mar 28, 2024 · Open, Classified
  RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.