Lower riskMedical device recall · FDA · Published February 10, 2025
Brainlab Origin Data Management Software Recalled: Patient Records Merged Without Notice
Brainlab recalls software versions 3.1.0-3.2.1 due to risk of merging unrelated patient records into one without user notification. Affected users should contact Brainlab for details.
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
“Brainlab Origin Data Management Software Recalled: Patient Records Merged Without Notice.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52928-brainlab-origin-data-management-software-recalled-patient-records-merged-without. Based on FDA recall #Z-1392-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1392-2025%22&limit=1).
The FDA announced on Feb. 10, 2025, that Brainlab AG is recalling Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, and 3.2.1 because patient records from unrelated individuals may be automatically merged without user notification.
Origin Data Management software version 3.1 (UPC: 04056481145118)
Origin Data Management software version 3.2 (UPC: 04056481146078)
The hazard
Under certain circumstances, patient records from unrelated individuals may be automatically merged into one patient record without user notification.
Context
GovInfoNow's records show Brainlab AG has issued 15 other recalls since July 28, 2017. Recent brand recalls include the March 2, 2023, Brainlab Cirq Arm System 2.0 recall for mechanical instability and the Feb. 14, 2023, Brainlab ExacTrac Software recall regarding Deep Inspiration Breath Hold functionality. Other recent recalls of similar products include the July 31, 2026, GE Healthcare Enterprise Archive V8 Software Recall and the June 30, 2026, Merge OrthoPACS Workstation Recalls.
How to tell if you have this one
Check if you have Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, or 3.2.1. The software version numbers are listed in the product description.
Brand
Brainlab
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your software version by checking the product description or documentation.
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 44 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-1392-2025 (February 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1392-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.