Radiation therapy planning system doses may be calculated incorrectly
Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.
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: FDA Class II medical device with a potential dose calculation error in radiation therapy planning software. No reported illnesses or injuries are documented, and the hazard represents a theoretical risk affecting treatment planning accuracy.
Plain-English summary
RayStation is a radiation therapy treatment planning system used by healthcare facilities to calculate and plan cancer radiation treatments. Certain versions (12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12, and 12.3.0.119) may report an incorrect Source-to-Surface Distance (SSD) value, a critical parameter used in dose calculation.
If the SSD is reported too high, dose calculations in the treatment plan may be inaccurate. This could impact the precision of radiation therapy dosing.
The recall affects 66 units distributed worldwide, including throughout the United States and in over 40 additional countries. Healthcare facilities and radiation oncology centers using these specific software versions should contact RaySearch Laboratories AB for verification guidance and software updates.
Patients and healthcare providers should not disregard existing treatment plans created with this software without consulting their radiation oncology team. The FDA and manufacturer recommend system verification and application of available software updates.
The recalled product
- Product
- RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. 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 (13)
- UDI: 0735000201042620211208
- 0735000201049520220312
- 0735000201050120220422
- 0735000201060020220620 and 0735000201057020221222
- GTIN: 07350002010426
- 07350002010495
- 07350002010501
- 07350002010600 and 07350002010570
- Serial Numbers: 12.0.0.932
- 12.1.0.1221
- 12.0.3.68
- 12.0.4.12 and 12.3.0.119
- Expiration Date: 2028-03-20.
Distribution
Distributed nationwide across the United States.
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