Terminated

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.

FDA Recall Z-0218-2016 · Posted None

Recalling FirmBrainlab AG

Recall StatusTerminated

Product CodeLLZ

Date Initiated2015-09-21

Date Terminated2017-04-24

Product Quantity897

Reason for Recall

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

Firm Action

Brainlab sent A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated 8/27/2015 to medical users regarding Content Manager, Patient Browser and the DICOM Viewer. The Product Notification letter decribes the corrective action information and to advise the medical users of the action Brainlab is taking to address the issue. If you require further clarification, the firm advises to contact the local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) E-mail: [email protected] (for US customers: [email protected]) Fax: Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093117DIGITAL LIGHTBOXBrainlab AG · 2009-12-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.