Z-1191-2025 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
- 32
Product Description
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
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: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 and 0735000201055620230630 GTIN: 07350002010549, 07350002010679, 07350002010730 and 07350002010556 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Revisions: RayStation 12A, 12A Service Pack 1 and 2 and 2023B Expiration Date: 2028-07-07