Medical Device Software May Merge Patient Records Without Notification
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is theoretical—patient records may be merged without notification—representing a risk-of-harm scenario without reported harm. Per the rubric, theoretical hazards score at most 3.
Plain-English summary
Brainlab AG has recalled Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, and 3.2.1. Under certain circumstances, the software can automatically merge patient records from unrelated individuals into a single patient record without notifying the user.
This data integrity issue creates a risk that clinical staff may unknowingly access and use incorrect patient information when making medical decisions, potentially compromising patient safety and the quality of clinical care.
The recalled software has been distributed worldwide with US nationwide distribution. Healthcare facilities and individuals using affected software versions should contact Brainlab AG for information about available software updates and recommended mitigations.
The recalled product
- Product
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- Manufacturer
- Brainlab AG
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Origin Data Management software version 3.1 is 04056481145118
- Origin Data Management software version 3.2 is 04056481146078
Distribution
Distributed nationwide across the United States.
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