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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Data Manager

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 Class 2 Device Recall Patient Data Managersee related information
Date Initiated by FirmSeptember 25, 2019
Create DateOctober 23, 2019
Recall Status1 Terminated 3 on March 25, 2024
Recall NumberZ-0176-2020
Recall Event ID 83978
Product Classification Digitizer, image, radiological - Product Code LMA
ProductPatient 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 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.
Code Information 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.
FEI Number 3002619595
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionAs 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.
Quantity in Commerce1230 units
Distributionworldwide
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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