Radiation therapy planning system may calculate patient doses too high
RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.
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 risk-of-harm product (radiation therapy planning system with potential for dose calculation errors) where no injuries or illnesses have been reported in the source text. Incorrect radiation dosing represents a serious potential hazard, but without reported patient harm, the score is 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
RayStation versions 10.1.0.613 and 10.1.1.54 are radiation therapy treatment planning systems used to calculate and deliver cancer treatment. The FDA has determined that these versions may calculate source-to-surface distance (SSD) values higher than they should be, which could result in patients receiving radiation doses higher than clinically intended.
Eighteen units of the affected software have been distributed worldwide, including to the United States and 40+ other countries. RaySearch Laboratories AB is the manufacturer and recalling firm.
Patients who have received radiation therapy treatment planned with the affected RayStation versions should contact their healthcare provider or cancer center to determine whether their treatment may have been affected. Healthcare facilities using these software versions should immediately discontinue use of affected versions and upgrade to a corrected version provided by the manufacturer.
The recalled product
- Product
- RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- radiation-overdose-risk
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: 0735000201031020201216 and 0735000201047120220128
- GTIN: 07350002010310 and 07350002010471
- Serial Numbers: 10.1.0.613 and 10.1.1.54
- Expiration Date: 2027-02-01.
Distribution
Distributed nationwide across the United States.
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