CLASS II ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report
RayStation -Intended as a Radiation Therapy Treatment recalled
Raysearch Laboratories AB is recalling RayStation -Intended as a Radiation Therapy Treatment Planning System, distributed nationwide in the US. The recall was initiated on 16 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1186-2025
- FDA event ID
- 96156
- Recalling firm
- Raysearch Laboratories AB, Stockholm, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2025
- FDA classified
- 19 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 16 Jan 2025 | Recall initiated by company | |
| 19 Feb 2025 | Classified by FDA | +34 days |
| 26 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1
Where it was distributed
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.
Questions about this recall
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.
Which lots are affected?
Lot Code: UDI: 0735000201011220180608, 0735000201013620180928, 0735000201017420190612 and 0735000201048820220420 GTIN: 07350002010112, 07350002010136, 07350002010174 and 07350002010488 Serial Numbers: 8.0.0.61, 8.0.1.10, 9.0.0.113 and 9.0.1.142 Software Revisions: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1 Expiration Date: 2027-12-15
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 96156This product is part of a recall event; the main page for the event is RayStation- Intended as a Radiation Therapy Treatment recalled.
More recalls from Raysearch Laboratories AB
All 115| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RayCare 2024A SP4 recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Other | Nationwide |
| Device | CLASS II | RayCare 2024A SP1 recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Other | Nationwide |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Device Malfunction | |
| Device | CLASS II | RayStation/RayPlan recalled by Raysearch Laboratories Ab | Raysearch Laboratories AB | Device Malfunction |
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