Recall Z-1392-2025 ยท LLZ System, Image Processing, Radiological
Brainlab AG
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
| Date | Mar 18, 2025 (initiated Feb 10, 2025) |
| Status | Open, Classified |
| 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 |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Brainlab AG, May 21, 2024 |