CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report

Origin Data Management recalled by Brainlab AG

Brainlab is recalling Origin Data Management, distributed nationwide in the US. The recall was initiated on 10 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOrigin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1392-2025
FDA event ID: 96241
Recalling firm: Brainlab, Munich, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 10 Feb 2025
FDA classified: 18 Mar 2025
Reported: 26 Mar 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

10 Feb 2025	Recall initiated by company
18 Mar 2025	Classified by FDA	+36 days
26 Mar 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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