11

Nov

2015

Cl II Brainlab Digital Lightbox

0

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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