Device 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.
Z-2134-2014
Product summary
- Firm
- Brainlab AG
- Event
- Event 68737
- Status
- Terminated
- Classification
- Class II
- Quantity
- 154 systems
- Official record key
device-enforcement:Z-2134-2014
Official wording
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
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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