Radiation Therapy Planning System May Calculate Skin Surface Distance Incorrectly
RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.
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 is a Class II FDA recall of a radiation therapy treatment planning system where the software may calculate critical dosing parameters incorrectly. While no patient injuries have been reported in the source text, the potential for dose miscalculation in radiation therapy represents a risk-of-harm scenario that justifies a High severity rating.
Plain-English summary
RayStation is a software-based radiation therapy treatment planning system used by healthcare facilities. Versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 have been recalled.
The recall concerns a potential issue where the software may calculate skin surface distance (SSD) values incorrectly. SSD is a critical parameter in radiation therapy treatment planning and dose calculations. Incorrect SSD values could affect treatment planning accuracy.
The affected software has been distributed worldwide. This recall involves 10 units.
The recalled product
- Product
- RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-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 (10)
- UDI: 0735000201038920210518
- 0735000201043320210610
- 0735000201044020210916 and 0735000201063120220616
- GTIN: 07350002010389
- 07350002010433
- 07350002010440 and 07350002010631
- Serial Numbers: 11.0.0.951
- 11.0.1.29
- 11.0.3.116 and 11.0.4.15
- Expiration Date: 2027-06-22.
Distribution
Distributed nationwide across the United States.
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