FDAClass IIMarch 26, 2025

Origin Data Management software versions 3.1.0 recall

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Why was Origin Data Management software versions 3.1.0 recalled?

Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Recalling firm
Brainlab AG
Quantity
N/A
Distribution
Worldwide - US Nationwide distribution.
Recall date
March 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls