Brainlab Patient Data Manager Software Recall for Data Export Errors
Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall, and the defect involves a risk of harm (incorrect data export) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Brainlab AG is recalling the Patient Data Manager (PDM) software, specifically versions 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, and 2.5.1. This recall involves 1,230 units distributed worldwide. The software is intended to load and export patient data to connected network locations and removable media, and to start other Brainlab planning and navigation applications.
The recall is due to a defect where shifts applied to segmentation objects in the iPlan CMF/Cranial/ENT/Spine software may not be reflected when exported into DICOM under specific circumstances. This issue occurs when the Patient Data Manager is used in combination with iPlan CMF/Cranial/ENT/Spine software versions 3.0.5 or 3.0.6.
Healthcare facilities and users of this software should contact Brainlab AG for instructions on how to resolve the issue. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA…
- Manufacturer
- Brainlab AG
- Category
- Medical Device — Software
- Affected units
- 1,230
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- GTIN 04056481006662 2.3.1
- GTIN 04056481132453 2.4.0
- GTIN 04056481138615 2.5.0
- GTIN 04056481140502 2.5.1
- GTIN 04056481140502 versions 2.1.1
- 2.2.0
- 2.2.1
- 2.3.0
- 2.3.1
- 2.4.0
- 2.5.0
- 2.5.1.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Brainlab AG
See all →- HighMedical Device Software May Merge Patient Records Without Notification
FDA (Devices) · 2025-03-26
- HighSurgical navigation system recalled for potential mechanical instability
FDA (Devices) · 2023-04-05
- HighRadiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold
FDA (Devices) · 2023-03-22
- HighExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning
FDA (Devices) · 2022-03-16
- HighRadiotherapy positioning software may delay patient movement display
FDA (Devices) · 2021-06-16
Same hazard · data integrity
See all →- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
Similar recalls
- HighBrainlab Patient Data Manager Software Recalled for Image Display Errors
FDA (Devices) · 2015-11-11
- ModerateBrainlab Patient Data Manager 2.0 Software Recall for Image Display Defects
FDA (Devices) · 2014-08-06
- HighMedical Device Software May Merge Patient Records Without Notification
FDA (Devices) · 2025-03-26
- HighGE Healthcare Recalls Carescape Patient Data Module Software
FDA (Devices) · 2012-12-26
- HighBrainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error
FDA (Devices) · 2014-08-20
- HighGE Healthcare Carescape Patient Data Module Recalled for ECG Calculation Errors
FDA (Devices) · 2014-10-15