RayStation radiation therapy planning system may report inaccurate dosimetry values
RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units 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 an FDA Class II recall of a critical radiation therapy planning system with a potential dosimetry calculation issue. However, the source text describes this as a potential issue with no reported illnesses, injuries, or deaths. Per the rubric, when hazards are explicitly stated as theoretical with no reported harm, the maximum score is 3.
Plain-English summary
RayStation 14.0.0.3338 is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB. The software is used to plan and optimize radiation therapy for cancer treatment by calculating appropriate radiation doses. According to the FDA recall notice, the software contains a potential issue where source-to-surface distance (SSD) values may be reported as higher than their actual measurements.
In radiation therapy, source-to-surface distance is a critical measurement parameter used in dosimetry calculations to ensure accurate radiation dose delivery to tumors and surrounding tissues. Incorrect SSD values could lead to improper dose calculations in treatment plans, potentially affecting the accuracy of therapy delivery.
The recall affects 49 units of RayStation version 14.0.0.3338 (serial number 14.0.0.3338) distributed worldwide, including the United States and over 40 additional countries across Europe, Asia, Africa, Australia, and the Middle East. The affected software expires July 7, 2028.
Healthcare facilities using this software version should contact RaySearch Laboratories AB through the FDA for remediation instructions, which may include a software update or patch. Facilities should review treatment plans generated with this version to determine if corrective measures are necessary.
The recalled product
- Product
- RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dosimetry-error
- dose-calculation-error
- software-malfunction
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 (4)
- UDI: 0735000201055620230630
- GTIN: 07350002010556
- Serial Numbers: 14.0.0.3338
- Expiration Date: 2028-07-07.
Distribution
Distributed nationwide across the United States.
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