Company: Brainlab AG
Date of Enforcement Report 11/11/2015
Class lI:
PRODUCT
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images. Recall Number Z-0218-2016
REASON
Potentially incorrectly displayed objects when actively deselecting a fused reference dataset
RECALLING FIRM/MANUFACTURER
Brainlab AG Feldkirchen, DE on 9/21/2015 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
897
DISTRIBUTION
Worldwide
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