RayStation radiation therapy system dosing parameter recall
RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.
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 risk-of-harm medical device product where incorrect treatment planning parameters could affect patient safety. The source text does not report any illnesses or injuries. As a Class II medical device without reported hospitalizations or injuries but with potential for patient harm, it meets the criteria for High severity.
Plain-English summary
RayStation 15.0.0.430, a radiation therapy treatment planning system manufactured by Raysearch Laboratories AB, is subject to recall due to a potential issue with the SSD parameter being too high.
The affected product is distributed worldwide, including throughout the United States and multiple international markets. This version includes specific serial numbers and unit identifiers documented in the recall notice. The issue involves a potential error in the SSD parameter critical to treatment planning calculations.
Patients and healthcare facilities using this software version should contact Raysearch Laboratories AB immediately to determine appropriate corrective actions or software updates.
The recalled product
- Product
- RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Affected units
- 3
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: 0735000201072320231213
- GTIN: 07350002010723
- Serial Numbers: 15.0.0.430
- Expiration Date: 2028-12-21.
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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