Z-1185-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2025
- Initiation Date
- January 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Lot Code: UDI: 0735000201006820171130, 0735000201011220180608 and 0735000201013620180928 GTIN: 07350002010068, 07350002010112 and 07350002010136 Serial Numbers: 7.0.0.19, 8.0.0.61 and 8.0.1.10 Software Revision: RayStation 7, 8A and 8A Service Pack 1 Expiration Date: 2023-10-04