Radiation Therapy Planning System May Report Dose Values Too High
RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units 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: FDA Class II device with potential to cause treatment planning errors in a high-risk medical application (radiation therapy). The source describes a potential defect but does not report any illnesses or injuries, so the score is at most 3 per the rubric.
Plain-English summary
RayStation versions 9.0.0.113 and 9.0.1.142, a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB, is being recalled due to a potential defect in dose reporting. The system may report dose values that are too high, which could affect the accuracy of radiation therapy dose calculations and treatment planning.
Approximately 63 units of the affected software versions have been distributed worldwide to medical facilities. The affected versions are identified by UDI 0735000201017420190612 and 0735000201048820220420, with expiration date 2027-12-15.
Radiation oncologists and medical physicists at facilities using the affected software versions should independently verify all dose calculations using alternative methods before finalizing treatment plans. Healthcare facilities should contact RaySearch Laboratories AB for guidance on updating to unaffected software versions.
The recalled product
- Product
- RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- radiation-dose-error
- software-defect
- treatment-planning-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: 0735000201017420190612 and 0735000201048820220420
- GTIN: 07350002010174 and 07350002010488
- Serial Numbers: 9.0.0.113 and 9.0.1.142
- Expiration Date: 2027-12-15.
Distribution
Distributed nationwide across the United States.
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