Reported Feb 26, 2025 · Ongoing
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19,…
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm, N/A · N/A
Is this the product you have?
- Brand NameRayStation Intended as a Radiation Therapy Treatment Planning System
- Model/Catalog Number
7.0.0.198.0.0.618.0.1.10
- Software Version
RayStation 78A and 8A Service Pack 1
- Lot codes and dates
- Lot Code
UDI: 07350002010068201711300735000201011220180608
- and 0735000201013620180928 GTIN
0735000201006807350002010112
- and 07350002010136 Serial Numbers
7.0.0.198.0.0.61 and 8.0.1.10
- Software Revision
RayStation 78A
- and 8A Service Pack 1 Expiration Date2023-10-04
- Lot Code
- Amount recalled
- 0
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Raysearch Laboratories Ab recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.