FDA Medical Device Recalls (openFDA)
Brainlab AG: Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- Recall number
- Z-1392-2025
- Recalling firm
- Brainlab AG
- Product
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
- Status
- Open, Classified
- Initiated
- 2025-02-10
- Posted
- 2025-03-18
- Terminated
- not on file
- Reason
- Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
- 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
- Quantity
- not on file
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
- 510(k) numbers
- ["K232759"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002619595
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28