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

Recalled November 11, 2015 · FDA recall Z-0218-2016 · Brainlab AG

Hazard

Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. · FDA Class II

Units

897

Sold at

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, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.

Description

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

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.

Manufacturer(s)

Brainlab AG

Made in

Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →