RayStation radiation therapy planning software affected by source-to-surface distance calculation error
RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are 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 radiation therapy treatment planning system, a critical medical device function. The hazard is a potential calculation error that could affect treatment planning accuracy. No illnesses, injuries, or deaths are reported. Per the severity rubric, risk-of-harm products without reported injury are scored High (3).
Plain-English summary
RayStation is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB. Versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 have been recalled due to a potential issue where source-to-surface distance (SSD) calculations may be too high.
Approximately 5 units of the affected software versions have been distributed worldwide, including in the United States and more than 40 other countries.
The recalled product
- Product
- RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Affected units
- 5
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: 0735000201011220180608 and 0735000201013620180928
- GTIN: 07350002010112 and 07350002010136
- Serial Numbers: 8.0.0.61 and 8.0.1.10
- Expiration Date: 2024-06-05.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by RAYSEARCH LABORATORIES AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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