RAYSEARCH LABORATORIES AB: Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Descri
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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
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
- 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
- Lot Code: UDI: 0735000201047120220131 GTIN: 07350002010471 Serial Numbers: 10.1.1.54 Software Revision: RayStation 10B SP1 Expiration Date: 2027-02-01
- Product quantity
- 0
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Stockholm
- Country
- Sweden
- Event id
- 98117
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