Recall Z-0218-2016— Brainlab AG

Name: FDA recall Z-0218-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-21

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2015-09-21, terminated 2017-04-24. It names one FDA 510(k) clearance: K093117. 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.. Reason: Potentially incorrectly displayed objects when actively deselecting a fused reference dataset..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Terminated: 2017-04-24
Firm location: Feldkirchen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K093117 — DIGITAL LIGHTBOXBrainlab AG·cleared 2009-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.