Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Summary
The FDA issued a Class II for Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 by Brainlab AG. Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without use.
Details
Source
Device Recall
External ID
Z-1392-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
Product Description
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Lot/Code Info: Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
Quantity Affected: N/A
Reason for Recall
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-10
Company
Munich, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Brainlab AG has 32 FDA actions in our database, including 4 recalls and 28 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Brainlab AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brainlab AG have FDA actions?
Brainlab AG has 32 FDA actions in our database, including 4 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1392-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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