Z-1190-2025 Class II Ongoing
FDA device recall Z-1190-2025 was initiated by RAYSEARCH LABORATORIES AB on January 16, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 5.
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
- 5
Product Description
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 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: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222 GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570 Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Revisions: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1 Expiration Date: 2028-03-20