RaySearch Ray Station 4.0 software recalled for dose calculation errors
RaySearch Laboratories is recalling Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves clinical dose calculation errors in radiation therapy, which poses a significant risk of harm to patients.
Plain-English summary
RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software, a stand-alone Radiation Therapy Treatment Planning System. The recall is due to clinical dose calculation errors that occurred during radiation therapy.
The recall involves 19 units of the software, with 16 units distributed domestically and 3 units internationally. The affected software is Model 4.30, Version 4.0.2.9, specifically those with 3D-CRT optimization or Fallback Planning Licenses. Distribution locations include Ohio, Maryland, New Jersey, Washington, Illinois, Massachusetts, Florida, Spain, the United Kingdom, and Italy.
Healthcare providers and patients should contact RaySearch Laboratories for further instructions regarding the recall and potential impact on treatment plans.
The recalled product
- Product
- RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Hazard
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 (3)
- Model#: 4.30
- Version: 4.0.2.9
- 3D-CRT optimization or Fallback Planning Licenses
Distribution
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