RAYSEARCH LABORATORIES AB: RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Read the official notice at FDA (device) →
Get alerts for Raysearch Laboratories Ab
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- RAYSEARCH LABORATORIES AB
- Product
- RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Recall initiated
- 2025-11-28
- Code info
- UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01.
- Product quantity
- 0
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Stockholm
- Country
- Sweden
- Event id
- 98117
Free daily digest + "My products" watchlist