FDA Device recall Z-0218-2016
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the disp…
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the disp… by Brainlab Ag, citing potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0218-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-21 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | US |
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.
Identifiers
| code_info | Potentially affected are Patient Data Manager versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0. Serial numbers/lot numbers a…Potentially affected are Patient Data Manager versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0. Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: Main model/catalogue numbers: 25121-01 PATIENT DATA MANAGER 2.0.0 LICENSE ONLY 25100-05 PATIENT DATA MANAGER 2.0.1 LICENSE ONLY 25100-06 PATIENT DATA MANAGER 2.0.2 LICENSE ONLY 25100-07 PATIENT DATA MANAGER 2.0.3 LICENSE ONLY 25100-08 Further the above listed main-articles are incorporated into the following model/catalogue numbers: 15600 MULTI-TOUCH INFORMATION GATEWAY 15610 IN-WALL MULTI-TOUCH INFORMATION GATEWAY 15700 CURVE CEILING-MOUNTED DUAL DISPLAY 15705 CURVE CEILING-MOUNTED SINGLE DISPLAY 15709-10 CURVE CM COMPUTER UNIT 18070 KICK NAVIGATION STATION 18071 KICK MONITOR CART 18071-19 KICK MONITOR CART BASE (WITH OS) 18073-17 KICK MCU (WITH OS) 18077 KICK UPGRADE NAVIGATION STATION 18078 KICK NAVIGATION STATION (REFURB. CAMERA) 18080 KICK NAVIGATION STATION 18080-01 KICK N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0218-2016%22
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