Z-0176-2020Class II

Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10...

Name: Z-0176-2020 Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10...
Creator: Brainlab AG
Published: 2019-09-25
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2019-09-25 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of 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 -... on 2019-09-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0176-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-25
Posted: 2019-10-23
Terminated: 2024-03-25
Recalling firm: Brainlab, Inc.
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 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.
Product code: LMA Digitizer, Image, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 1230 units
Distribution: worldwide
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0176-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0176-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-23

Product code LMA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)