Recall Z-0218-2016 ยท LLZ System, Image Processing, Radiological
Brainlab AG
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 (reconstruct
| Date | Sep 21, 2015 |
| Status | Terminated |
| Reason | Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. |
| Root cause | Software design |
| 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: support@brainlab.com (for US customers: us.support@brainlab.com) Fax: |
| Quantity | 897 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093117 | DIGITAL LIGHTBOX Brainlab AG, Dec 11, 2009 |