The Recall Desk
HighFDA (Devices)·Z-1110-2026·Announced 2026-01-28

[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Soft

Pending LLM rewrite. Source: FDA_DEVICE Z-1110-2026.

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
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
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 (5)

  • Lot Code: UDI: 0735000201082220250423
  • 0735000201094520250702 GTIN: 07350002010822
  • 07350002010945 Serial Numbers: 17.0.0.1270
  • 17.0.1.113 Software Revision: RayStation v2025
  • RayStation v2025 SP1 Expiration Date: 2030-10-22

Distribution

Distribution scope not specified by the agency.

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