RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software version 4.0.3.4
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- RAYSEARCH LABORATORIES AB
- Reason for Recall:
- This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
Product Codes/Lot Numbers:
Software version 4.0.3.4
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1806-2014
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DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.