HIGH

RaySearch Laboratories Recalls RayStation Software Over Dose Calculation Error

RaySearch Laboratories recalled RayStation software on November 28, 2025, due to a potential error in calculating radiation doses. The recall affects 119 units of software versions 14.0.0, 15.0.0, and 15.1.3. Healthcare providers should stop using the software immediately to ensure patient safety.

Quick Facts at a Glance

Recall Date
November 28, 2025
Hazard Level
HIGH
Brand
RAYSEARCH LABORATORIES AB
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

RayStation is a radiation therapy treatment planning system used by healthcare providers to calculate and deliver accurate radiation doses to patients. It is crucial for ensuring effective treatment in cancer therapies.

Why This Is Dangerous

The software's failure to accurately invalidate a calculated radiation dose for certain Regions of Interest can lead to improper treatment planning, potentially endangering patient health.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare providers and patients relying on accurate dosing for radiation therapy, emphasizing the urgency for immediate action to prevent potential health risks.

Practical Guidance

How to identify if yours is affected

  1. Check if your software version is 14.0.0, 15.0.0, or 15.1.3.
  2. Verify if your software has been distributed in the recall notice.
  3. Contact your healthcare provider for confirmation.

Where to find product info

Software versions can typically be found in the application settings or about section of the software.

What timeline to expect

Refund or replacement processing typically takes 4-8 weeks.

If the manufacturer is unresponsive

  • Follow up with the manufacturer via email.
  • Document all communications for future reference.
  • Consider escalating the issue to relevant health authorities if you receive no response.

How to prevent similar issues

  • Always verify software updates and recalls regularly.
  • Ensure thorough training for healthcare providers on software functionalities.
  • Look for software with strong safety records and certifications.

Documentation advice

Keep records of your purchase, any communications regarding the recall, and screenshots of the software version.

Product Details

The recall impacts RayStation and RayPlan software versions 14.0.0, 15.0.0, 15.1.3, RayStation 2023B, RayStation 2024A, and RayStation 2024A SP3. The software was distributed to healthcare facilities in the United States and other countries.

Key Facts

  • Recall date: November 28, 2025
  • Report date: January 28, 2026
  • 119 units affected
  • Software versions: 14.0.0, 15.0.0, 15.1.3
  • High hazard level

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeRadiation Therapy Treatment Planning System
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot Code: UDI: 0735000201055620230630
0735000201072320231213
0735000201088420250129 GTIN: 07350002010556
07350002010723
07350002010884 Serial Numbers: 14.0.0.3338
+4 more
Report Date
January 28, 2026
Recall Status
ACTIVE

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