Events

Recall of Brainlab AG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brainlab AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72236
  • Event Risk Class
    Class 2
  • Event Number
    Z-0218-2016
  • Event Initiated Date
    2015-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140308
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
  • 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.

Device

Brainlab AG
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • 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.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Manufacturer Address
    Brainlab AG, Kapellenstr. 12, Feldkirchen Germany
  • Manufacturer Parent Company (2017)
    Brainlab AG
  • Source
    USFDA