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 recalls specific versions of its Origin Data Management software because it can accidentally merge patient records from different people into a single record without warning. This could lead to medical errors if the merged records are used for treatment decisions.
The software may automatically combine patient records from different individuals into one record without the user being aware. This could cause medical errors if the merged records are used for treatment decisions, potentially affecting patient care.
Healthcare providers using Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 are likely affected. Medical staff handling patient records with these versions face the highest risk of record confusion.
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.
Identify your software version by checking the product description or documentation.
Software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, and 3.2.1 are affected.
Patient records from unrelated individuals may be automatically merged into one record without user notification, potentially leading to medical errors.
Check your software version and contact Brainlab for further instructions.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1392-2025 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1392-2025 from Brainlab. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
