Brainlab AG recalls Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system i…

Recall date

September 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0218-2016

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Lithuani…

Why it was recalled

Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.