The Recall Desk
HighFDA (Devices)·Z-1103-2026·Announced 2026-01-28

RayStation 11A treatment planning recalled over dose that fails to invalidate

RaySearch Laboratories is recalling RayStation/RayPlan models 11.0.0, 11.0.1, 11.0.3 and 11.0.4 because calculated radiation dose is not invalidated as intended for certain regions of interest.

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: Scored 3 under the risk-of-harm criterion: a calculated radiation dose that is not invalidated when it should be can be used for planning, and no injuries are reported.

Plain-English summary

RayStation/RayPlan, a radiation therapy treatment planning system, models 11.0.0, 11.0.1, 11.0.3 and 11.0.4, software versions RayStation 11A, RayStation 11A SP1, RayStation 11A SP2 and RayStation 11A SP3, is being recalled by RaySearch Laboratories AB.

The record states there is a potential for the invalidation for calculated radiation dose not to work as intended for certain Regions of Interest (ROIs). The issue occurs for some ROIs 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 record lists 10 units. Rather than naming territories, the record refers to attached distribution lists, 'Distribution list 167168 US - updated' and 'Distribution list 167168 OUS'. UDI, GTIN and serial numbers are recorded in the enforcement record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Sites should follow RaySearch's instructions.

The recalled product

Product
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Treatment planning software
Hazard
Affected units
10

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 (13)

  • Lot Code: UDI: 0735000201038920210518
  • 0735000201043320210610
  • 0735000201044020210916
  • 35000201063120220616. GTIN: 07350002010389
  • 07350002010433
  • 07350002010440
  • 07350002010631. Serial Numbers: 11.0.0.951
  • 11.0.1.29
  • 11.0.3.116
  • 11.0.4.15. Software Revision: RayStation 11A
  • 11A SP1
  • 11A SP2
  • 11A SP3. Expiration Date: 2027-06-22.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 9 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · RAYSEARCH LABORATORIES AB

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Same hazard · dose invalidation

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