ProductGuru Recalls

Official recall record

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStati

US FDA — Medical Devices · 2025-11-28 · SwedenClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2025-11-28
Country of alert
Sweden
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
07350002010822
Brand on record
RAYSEARCH LABORATORIES AB

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · Sweden · all filters

Other recalls from this brand

All 15 official recall notices naming RAYSEARCH LABORATORIES AB on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.