The Recall Desk
HighFDA (Devices)·Z-1104-2026·Announced 2026-01-28

[pending] RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Versio

Pending LLM rewrite. Source: FDA_DEVICE Z-1104-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • UDI: 0735000201042620211208
  • 0735000201049520220312
  • 0735000201050120220422
  • 0735000201060020220620 and 0735000201057020221222. GTIN: 07350002010426
  • 07350002010495
  • 07350002010501
  • 07350002010600 and 07350002010570. Serial Numbers: 12.0.0.932
  • 12.1.0.1221
  • 12.0.3.68
  • 12.0.4.12
  • 12.3.0.119. Software Revisions: RayStation 11B
  • 11B SP1
  • 11B SP2
  • 11B SP3
  • 11B SPT1. Expiration Date: 2028-03-20.

Distribution

Distribution scope not specified by the agency.

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