RayStation Radiation Therapy System Recalled for Potential Dosing Error
RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.
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: This Class II recall involves a radiation therapy treatment planning system with a potential software defect affecting dose calculations. Although the defect could result in significant harm through incorrect radiation dose delivery, no illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, recalls with theoretical hazards and no reported harm are scored at most 3 (High).
Plain-English summary
RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems manufactured by RaySearch Laboratories AB are subject to a Class II FDA recall. Approximately 128 units of these medical devices have been distributed worldwide, including throughout the United States and to numerous countries internationally.
The systems contain a potential software defect that could cause source-to-surface distance (SSD) calculations to be too high. Source-to-surface distance is a critical parameter in radiation therapy treatment planning. If this calculation is incorrect, the system may generate inaccurate radiation dose recommendations for cancer patients.
No illnesses or injuries have been reported to the FDA in connection with this defect. Healthcare facilities using the affected RayStation versions should contact RaySearch Laboratories AB to obtain corrected software or information about remediation. Patients who received treatment with these systems should consult their radiation oncology team if they have concerns about their care.
The recalled product
- Product
- RayStation 13.0.0.1547, 13.1.0.144 & 13.1.1.89. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- radiation-dosing-error
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 (7)
- UDI: 0735000201054920220616
- 0735000201067920221007 and 0735000201073020230913
- GTIN: 07350002010549
- 07350002010679 and 07350002010730
- Serial Numbers: 13.0.0.1547
- 13.1.0.144 and 13.1.1.89
- Expiration Date: 2028-10-05.
Distribution
Distributed nationwide across the United States.
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