Radiation therapy planning system dose calculation error
RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were 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 a Class II medical device recall involving a potential dose calculation error in a safety-critical radiation therapy treatment planning system. Although no patient illnesses or injuries have been reported, incorrect dose calculations in radiation therapy represent a significant risk of patient harm, warranting a High severity classification.
Plain-English summary
RayStation versions 9.1.0.933 and 9.2.0.483, a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB, has been recalled due to a potential error in dose calculations. The software may report the Source Skin Distance (SSD) as too high, which could affect radiation dose calculations in treatment planning.
11 units of the affected software were distributed worldwide, including in the United States and internationally.
Healthcare facilities using affected versions of RayStation should contact RaySearch Laboratories AB for corrective software updates or guidance on affected systems. Users should verify their installed software version and take appropriate action if affected.
The recalled product
- Product
- RayStation 9.1.0.933 and 9.2.0.483. 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 (4)
- UDI: 0735000201026620191220 and 0735000201029720200310
- GTIN: 07350002010266 and 07350002010297
- Serial Numbers: 9.1.0.933 and 9.2.0.483
- Expiration Date: 2025-03-31.
Distribution
Distributed nationwide across the United States.
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