The Recall Desk
HighFDA (Devices)·Z-1105-2026·Announced 2026-01-28

[pending] Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.

Pending LLM rewrite. Source: FDA_DEVICE Z-1105-2026.

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: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 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 (9)

  • Lot Code: UDI: 0735000201054920220616
  • 0735000201067920221007
  • 0735000201073020230913 GTIN: 07350002010549
  • 07350002010679
  • 07350002010730 Serial Numbers: 13.0.0.1547
  • 13.1.0.144
  • 13.1.1.89 Software Revisions: RayStation 12A
  • 12A SP 1
  • 12A SP2 Expiration Date: 2028-07-07

Distribution

Distribution scope not specified by the agency.

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