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.

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

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].