Lower riskMedical device recall · FDA · Published March 3, 2021
RayCare 3B software update may cause patient data loss during upgrade
RaySearch Laboratories recalls RayCare 3B software version 3.1.0.60341 for potential patient data loss when upgrading from older versions. Affected healthcare systems should check their software version.
Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later
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Contact the company
📍Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer
RaySearch Laboratories is recalling a specific version of their RayCare 3B oncology software due to a risk that patient information could be lost during upgrades from older versions. This affects healthcare facilities using the software for cancer care. Read more at govinfonow.com/recall/63172-raycare-3b-software-update-may-cause-patient-data-loss-during.
“RayCare 3B software update may cause patient data loss during upgrade.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63172-raycare-3b-software-update-may-cause-patient-data-loss-during. Based on FDA recall #Z-1281-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1281-2021%22&limit=1).
The FDA announced on March 3, 2021, that RaySearch Laboratories AB is voluntarily recalling RayCare 3B (3.1.0.60341) oncology information system software. The hazard involves the potential loss of patient-related messages when upgrading from RayCare 2 to RayCare 3B or later versions.
How to tell if you have it
Brand: RaySearch Laboratories
Product: RayCare 3B (3.1.0.60341)
Software Version: 3.1.0.60341
UDI: 0735000201028020191220
The hazard
Patient-related messages created in RayCare 3B will be lost when upgrading from RayCare 2 to RayCare 3B or later, according to the FDA. The recall classification is Class II.
Context
GovInfoNow's records show RaySearch Laboratories AB has issued 36 other recalls since July 17, 2017. Other recent recalls of similar products include Philips Azurion System Software R3.1 May Cause Imaging Loss (Dec. 12, 2025), GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026), and GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (July 31, 2026).
How to tell if you have this one
Check if your RayCare 3B software shows version 3.1.0.60341. The software is used in healthcare settings for cancer care and was sold with the serial number 3.1.0.60341.
Brand
RaySearch Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your RayCare 3B software version by checking the system settings or documentation.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 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-1281-2021 (March 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1281-2021 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.