Z-1392-2025Class II

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

Name: Z-1392-2025 Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Creator: Brainlab AG
Published: 2025-02-10
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2025-02-10 / Open, Classified / root cause: software

FDA source

Brainlab AG began a recall of Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 on 2025-02-10. FDA classified it as Class II and gives the reason as "Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1392-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-10
Posted: 2025-03-18
Recalling firm: Brainlab, Inc.
Product: Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter was sent to customers beginning 2/10/25. User Corrective Action: According to our records, at least one of the affected software versions is installed at your site. Therefore, when handling patient data intended to be used with Brainlab Software, adhere to the following instructions: Sequence 1 (Gender) " Do not edit only the Gender field of any already merged/edited patient record. (In the Patient Selection application, such a patient record is displayed with a Restore button next to it.) " For patient records that have not already been merged/edited, adapt all necessary fields including Gender in one single operation using Edit. Only then can you merge additional patient records to the edited patient record, if applicable. (In the Patient Selection application, such a patient record does not have a Restore button next to it.) Sequence 2 (ID) " Do not edit a Patient ID to a value that was the original ID of a previously merged/edited unrelated patient record. To verify whether a Patient ID has been previously used, perform the following steps before making any edits that affect Patient ID: 1. Search for the Patient ID that you want to use as the target ID in the search field in Patient Selection (do not use the Advanced Search). 2. If entries with the Restore button are shown in the patient list, - AND the searched Patient ID is not displayed - AND the Patient Name does NOT correspond to the individual intended to be treated, do not proceed with editing or merging and contact Brainlab support. For merges/edits originating externally from a Hospital Information System (HIS) that is connected to the above-listed versions of Brainlab ODM software: " Contact your HIS administrator (for the ADT interface) and clarify whether ADT A40 (merge patient) messages are used to edit Patient IDs in the system. If Patient IDs are changed via ADT A40 messages, contact Brainlab support so that we can verify whether our s
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-18

Product code LLZ

K232759Class IIViewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AG / cleared 2024-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)