Brand Name: RayStation- Intended as a Radiation Therapy recall
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version…
Why was Brand Name: RayStation- Intended as a Radiation Therapy recalled?
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: UDI: 0735000201002020170502 GTIN: 07350002010020 Serial Numbers: 5.0.2.35 and 5.0.3.17 Software Revisions: RayStation 5 Service Pack 2 and 3 Expiration Date: 2028-12-21
- Product
- Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version…
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 0
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.
- Recall date
- February 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)