RaySearch Laboratories recalls software version 8.1.2.5 for potential incorrect treatment planning calculations. Users should contact the company for updates.
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Take action
Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer
RaySearch Laboratories is recalling a specific software update for their radiation treatment planning system. This update could cause incorrect treatment calculations if pitch or roll corrections are applied, which might lead to unsafe radiation dosing. Read more at govinfonow.com/recall/65798-raystation-rayplan-8b-software-update-8-1-2-5-potential.
“RayStation/RayPlan 8B Software Update 8.1.2.5: Potential Incorrect Treatment Planning.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65798-raystation-rayplan-8b-software-update-8-1-2-5-potential. Based on FDA recall #Z-1466-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1466-2020%22&limit=1).
The FDA announced on Feb. 20, 2020, that RaySearch Laboratories AB voluntarily recalled its RayStation/RayPlan 8B Service Pack 2 stand-alone software treatment planning system due to a potential for erroneous propagation of current tabletop positions. The agency said the hazard involves incorrect lateral, longitudinal and vertical values when pitch or roll correction is applied.
How to tell if you have it
Brand: RaySearch Laboratories
Product: RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5
UDI: 07350002010235
Quantity: 1 system in the U.S.
Distribution: TN
The hazard
According to the FDA, there is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
Context
GovInfoNow's records show RaySearch Laboratories AB has 36 other recalls on record since July 17, 2017. Other recent recalls of similar products include RayCare 2:024A SP1 Oncology Software Data Loss Risk (May 20, 2026), RayStation Software Version 12A Recalls (Nov. 28, 2025), and RayStation 10B Software Version 10.1.0.613 (Aug. 8, 2025). Other recent recalls of similar products include Elekta Leksell GammaPlan software version 11.3/11.4 recall (Dec. 12, 2025), Elekta Leksell GammaPlan 11.1 Software Recall (Dec. 12, 2025), and Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (June 19, 2026).
How to tell if you have this one
Check if you have RayStation or RayPlan software version 8B Service Pack 2 with build number 8.1.2.5. The unique device identifier (UDI) is 07350002010235.
Brand
RaySearch Laboratories
Category
Medical device
FDA recall event · 7 products
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
The products were distributed to the following US states: TN
Reach out to RaySearch Laboratories for guidance on the specific software version and remedy.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1466-2020 (February 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1466-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.