FDA Medical devices recall ·
RayStation -Intended as a Radiation Therapy Treatment Planning System Model recall
- Recall number
- Z-1187-2025
- Date
- (initiated January 16, 2025)
- Company / brand
- Raysearch Laboratories Ab
Eugeniavagen 18c, Stockholm, N/A, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI: 0735000201026620191220, 0735000201029720200310, 0735000201030320200526, 0735000201036520200526 and 0735000201065520220608 GTIN: 07350002010266 and 07350002010297, 07350002010303, 07350002010365 and 07350002010655 Serial Numbers: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Revisions: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2 Expiration Date: 2025-06-16
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1187-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.