RayStation 7.0.0.19 radiation therapy planning software recalled for dose calculation error
RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 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 medical device with a potential dosage calculation error in safety-critical radiation therapy planning software. No reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not been reported are scored as High (3).
Plain-English summary
RayStation 7.0.0.19 is a radiation therapy treatment planning system manufactured by RaySearch Laboratories AB. The recall affects 14 units that have been distributed worldwide to the United States and 45+ countries including Canada, Japan, Australia, and throughout Europe.
The recall has been initiated due to a potential error in source-to-surface distance (SSD) calculations. SSD is a critical measurement used in radiation therapy treatment planning to calculate accurate radiation dose delivery. If SSD values are reported as too high, this could affect the accuracy of radiation dose calculations in treatment plans created using this system.
This is an FDA Class II recall. No injuries or illnesses have been reported in connection with this issue. However, errors in dose calculation in radiation therapy treatment planning software represent a potential patient safety risk.
The recalled product
- Product
- RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
- dose-calculation-error
- 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: 0735000201006820171130
- GTIN: 07350002010068
- Serial Numbers: 7.0.0.19
- Expiration Date: 2022-10-04.
Distribution
Distributed nationwide across the United States.
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