FDA Medical Device Recalls (openFDA)
Brainlab AG: 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.
- Recall number
- Z-2134-2014
- Recalling firm
- Brainlab AG
- 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.
- Status
- Terminated
- Initiated
- 2014-06-27
- Posted
- 2014-07-30
- Terminated
- 2017-04-24
- Reason
- 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
- 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 us.support@brainlab.com.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K093117"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002619595
- Firm city
- Feldkirchen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28