Class 2 Device Recall Origin Data Management

• Date Initiated by Firm: February 10, 2025
• Date Posted: March 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1392-2025
• Recall Event ID: 96241
• 510(K)Number: K232759
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
• Code Information: Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078
• Recalling Firm/ Manufacturer: Brainlab AG; Olof-Palme-Str. 9; Munich Germany
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LLZ