Radiation therapy planning system may report overly high skin surface doses
RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.
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 medical device recall involving a radiation therapy treatment planning system with potential for incorrect dose calculations. The source text describes only a potential issue with no reported incidents or injuries. Per the severity rubric, this qualifies as High (Score 3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
RayStation versions 8.0.0.61 and 8.0.1.10 are radiation therapy treatment planning systems manufactured by RaySearch Laboratories AB. These software versions are being recalled due to a potential issue where calculated skin surface doses (SSD) may be reported as too high.
The affected software versions have been distributed worldwide throughout the United States and numerous other countries, with 9 units distributed total. Skin surface dose is a critical parameter in radiation therapy planning, and potentially incorrect dose values could affect treatment plan calculations.
Healthcare facilities currently using these software versions should contact RaySearch Laboratories AB for a corrective software update and guidance on addressing the potential dosing issue.
The recalled product
- Product
- RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dosage-miscalculation
- radiation-overdose
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 (3)
- UDI: 0735000201011220180608 and 0735000201013620180928
- GTIN: 07350002010112 and 07350002010136
- Expiration Date: 2023-10-04.
Distribution
Distributed nationwide across the United States.
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