Brainlab AG Olof-palme-str. 9 Munich Germany 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 MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER
Brand
Brainlab AG Olof-palme-str. 9 Munich Germany
Lot Codes / Batch Numbers
Patient Data Manager versions 2.1.1 no GTIN 2.2.0 no GTIN 2.2.1 no GTIN 2.3.0, 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.
Products Sold
Patient Data Manager versions 2.1.1 no GTIN 2.2.0 no GTIN 2.2.1 no GTIN 2.3.0, 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.
Brainlab AG Olof-palme-str. 9 Munich Germany is recalling Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY due to The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.
Recommended Action
Per FDA guidance
As of September 25, 2019 for new installations or updates/upgrades to the affected SW version, the Field Safety Notice / Product Notification letter is hand delivered to the customer during installation (before clinical use) by the according Brainlab Service representative All other consignees were notified by email on 10/04/2019. The letter details how the even occurs and provides instruction on how to avoid the issue until a software revision is disseminated.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026