Lower riskMedical device recall · FDA · Published May 20, 2026
RayCare 2:024A SP1 Oncology Software Data Loss Risk
RaySearch Laboratories recalls RayCare 2024A SP1 software version 8.0.1.60193 due to potential data loss if beam set delivery notes are modified during treatment sessions.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
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📍Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden
✎ GovInfoNow plain-language explainer
RaySearch Laboratories is recalling its RayCare 2024A SP1 oncology software version 8.0.1.60193. This version may cause data loss if beam set delivery notes are updated or modified during treatment sessions without user notification. Read more at govinfonow.com/recall/49134-raycare-2-024a-sp1-oncology-software-data-loss-risk.
“RayCare 2:024A SP1 Oncology Software Data Loss Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49134-raycare-2-024a-sp1-oncology-software-data-loss-risk. Based on FDA recall #Z-2646-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2646-2026%22&limit=1).
The FDA announced on May 20, 2026, that RaySearch Laboratories AB is recalling RayCare 2024A SP1 Oncology Information Systems due to potential data loss if beam set delivery notes are modified simultaneously or during a treatment session. The agency issued recall number Z-2646-2026 for the voluntary Class II action affecting three units distributed nationwide in the U.S.
How to tell if you have it
Brand: RaySearch Laboratories
Product: RayCare 2024A SP1 Oncology Information Systems
Software Version: 8.0.1.60193
UDI: 0735000201083920240906
Expiration Date: 2030-01-24
The hazard
According to the FDA, the hazard involves beam set delivery note issues where there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session. In these scenarios, the user is not notified of the change.
Context
GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Recent brand recalls include a Nov. 28, 2025, recall for RayStation/RayPlan Software 11A regarding radiation dose calculation risks and an Aug. 8, 2025, recall for RayStation Software Versions 7.0.0.19 and 8.0.0.61 concerning unique DICOM IDs. Other recent recalls of similar products include the May 21, 2026, Elekta MOSAIQ Oncology System Software Recall for treatment plan loading risks and the Dec. 12, 2025, Elekta Leksell GammaPlan 11.1 Software Recall for incorrect patient irradiation risks.
How to tell if you have this one
Check for software version 8.0.1.60193 on RayCare 2024A SP1 systems. The recall covers products sold with UDI 0735000201083920240906.
Brand
RaySearch Laboratories
Category
Medical device
FDA recall event · 2 products
All 2 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
Ongoing
Distribution
Worldwide - US Nationwide distribution.
Recall number
Product, codes & lots
Z-2646-2026
RayCare 2024A SP1. Oncology Information Systems.; Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Z-2647-2026
RayCare 2024A SP4. Oncology Information Systems.; Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your RayCare 2024A SP1 software version is 8.0.1.60193.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2646-2026 (May 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2646-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.