FDAFDA · Food and drugs·Recall number Z-1110-2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Published January 28, 2026 · Recall initiated: November 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Distributor
- Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Lot
- Lot Code: UDI: 0735000201082220250423, 0735000201094520250702 GTIN: 07350002010822, 07350002010945 Serial Numbers: 17.0.0.1270, 17.0.1.113 Software Revision: RayStation v2025, RayStation v2025 SP1 Expiration Date: 2030-10-22
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.