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U.S. Department of Health and Human Services

Class 2 Device Recall Brainlab AG

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  Class 2 Device Recall Brainlab AG see related information
Date Initiated by Firm September 21, 2015
Create Date November 05, 2015
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-0218-2016
Recall Event ID 72236
510(K)Number K093117  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information 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 NAVIGATION STATION BRAZIL 18080-02 KICK NAVIGATION STATION CHINA 18081 KICK DPS MONITOR CART 18081-19 KICK DPS MONITOR CART BASE (WITH OS) 18083-17 KICK DPS MCU (WITH OS) 18090 KICK EM NAVIGATION STATION 19900 CURVE DUAL DISPLAY NAVIGATION STATION 19900-04B MONITOR CART-CURVE DUAL DISPL. SPAREPART 19900-04C MONITOR CART-CURVE DUAL DISPL. SPAREPART 19905 CURVE SINGLE DISPLAY NAVIGATION STATION 19905-04B MONITOR CART-CURVE SINGLE DISP SPAREPART 22216 CRANIAL NAVIGATION SW 3.0 22217 ENT NAVIGATION SW 3.0 22241 NAVIGATION SW ENT EM 1.0 22241-01 NAVIGATION SW ENT EM 1.0 - FOR BENELUX 22244 NAV SW ENT EM 1.0 ADD-ON FOR OPT NAV 22245 NAV SW ENT OPTICAL ADDON FOR ENT EM NAV 22267 SPINE & TRAUMA 3D (VER. 2.1) 25100C PATIENT BROWSER AND CONTENT MANAGER 25100D PATIENT BROWSER AND CONTENT MANAGER 25110 BRAINLAB SESSION SHARING NURSE STATION 25121 PATIENT BROWSER AND CONTENT MANAGER 26201-12A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201-36A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201-60A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26243A UPGRADE TO ORIGIN DATA MANAGEMENT 26269-12A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269-36A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269-60A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26282 UPGRADE TO ORIGIN DATA MANAGEMENT FOC 26290 ELEMENTS PLANNING SUITE FOR NAVIGATION 26291 ELEMENTS PLANNING SUITE FOR BUZZ 27001 NAVIGATION SOFTWARE KNEE 3 27003 NAVIGATION SOFTWARE KNEE 3 BASE SOFTWARE 27004 UPG NAVIGATION SOFTWARE KNEE 3 BASE SW 27006 UPG NAVIGATION SOFTWARE KNEE 3 BASE SW 27007 NAVIGATION SOFTWARE KNEE3  UNIVERSAL 30038A ORIGIN DATA MANAGEMENT 30039 ORIGIN DATA MANAGEMENT ORTHO 70346 UPD PATIENT BROWSER&CONTENT MANAGER 2.X 70349 UPD PACKAGE PDM 1.X TO 2.X INCL ELEMENTS 71201 UPG TO NAV SW CRAN 3.0 FROM CRAN 2.X 71202 UPG TO CRANIAL NAV SW 3.0 FROM ANY PREV 71202 UPG TO CRANIAL NAV SW 3.0 FROM ANY PREV 71203 UPG TO NAV SW ENT 3.0 FROM ENT 2.X 71204 UPG TO ENT NAV SW 3.0 FROM ANY PREV E15600 MULTI-TOUCH INFORMATION GATEWAY E15709-10 CURVE CM COMPUTER UNIT E18073-17 KICK MCU (WITH OS) E19900 CURVE DUAL DISPLAY NAVIGATION STATION E19900-04B MONITOR CART-CURVE DUAL DISPL. SPAREPART E19900-04C MONITOR CART-CURVE DUAL DISPL. SPAREPART E19900-05 MONITOR CART-CURVE BYPASS 2 DISP SPARE E19905 CURVE SINGLE DISPLAY NAVIGATION STATION E19905-04B MONITOR CART-CURVE SINGLE DISP SPAREPART E19905-05 MONITOR CART-CURVE BYPASS 1 DISP SPARE
Recalling Firm/
Manufacturer		 Brainlab AG
Kapellenstr. 12
Feldkirchen Germany
Manufacturer Reason
for Recall		 Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
FDA Determined
Cause 2		 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: Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = BRAINLAB AG
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