Z-2134-2014Class II

Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital...

Name: Z-2134-2014 Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital...
Creator: Brainlab AG
Published: 2014-06-27
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-06-27 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images... on 2014-06-27. FDA classified it as Class II and gives the reason as "The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is...". 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-2134-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-27
Posted: 2014-07-30
Terminated: 2017-04-24
Recalling firm: Brainlab, Inc.
Product: Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to
Root cause tag: software
FDA root cause: Software design
Action: FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated June 27, 2014 were sent to all direct accounts. The letters instruct product users to not upload image data sets with non-square pixels and to verify with their radiology department the modalities of the different imaging devices (e.g. CT, MRT, PET, ultrasound) from which data may be loaded onto a Brainlab device. Brain lab will provide a software update with this issue solved to affected customers with a tentative planned time line of availability being July 2014. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at [email protected].
Quantity in commerce: 154 systems
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
Product codes and lots: Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2. Software Versions: 2.0.0, 2.0.1, and 2.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-30

Product code LLZ

K093117Class IIDigital LightboxBrainlab AG / cleared 2009-12-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)