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U.S. Department of Health and Human Services

Class 1 Device Recall Brainlab Cranial Navigation System

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  Class 1 Device Recall Brainlab Cranial Navigation System see related information
Date Initiated by Firm April 22, 2013
Create Date January 19, 2016
Recall Status1 Open3, Classified
Recall Number Z-0598-2016
Recall Event ID 71924
510(K)Number K092467  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments.

The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Code Information AD FROM 2.1 , Serial Numbers: 000000000051714001 ,, 000000005104313001 ,, 000000006146515001 ,, 000000006146615001 ,, 000000006146715001 ,, 000000006146815001 ,, 000000007622015001 ,, 000000009289414001 ; , 26) Model 22214A , CRANIAL NAVIGATION SW 2.1.1 , Serial Numbers: 000000000052612001 ,, 000000000052712001 ,, 000000000055912001 ,, 000000000157012001 ,, 000000008553411001 ,, 000000008598111001 ,, 000000008615711001 ,, 000000008624811001 ,, 000000008674211001 ,, 000000008700211001 ,, 000000008714811001 ,, 000000008715911001 ,, 000000008766711001 ,, 000000008795711001 ,, 000000008844011001 ,, 000000008848411001 ,, 000000008861911001 ,, 000000008874011001 ,, 000000008902511001 ,, 000000008947212001 ,, 000000008968312001 ,, 000000009013812001 ,, 000000009022712001 ,, 000000009043912001 ,, 000000009053712001 ,, 000000009106912001 ,, 000000009133112001 ,, 000000009133612001 ,, 000000009134012001 ,, 000000009168512001 ,, 000000009306012001 ,, 000000009342012001 ,, 000000009382912001 ,, 000000009395512001 ,, 000000009401412001 ,, 000000009461012001 ,, 000000009505812001 ,, 000000009551212001 ,, 000000009559212001 ,, 000000009573412001 ,, 000000009647912001 ,, 000000009654412001 ,, 000000009654612001 ,, 000000009745412001 ,, 000000009763112001 ,, 000000009787112001 ,, 000000009788212001 ,, 000000009816112001 ,, 000000009816212001 ,, 000000009819512001 ,, 000000009867212001 ,, 000000009885512001 ,, 000000009926512001 ,, 000000009944112001 ,, 000000009951112001 ,, 000000009964612001 ; , 27) Model 22214B , CRANIAL NAVIGATION SW 2.1.1 , Serial Numbers: 000000000240112001 ,, 000000000240212001 ,, 000000000254712001 ,, 000000000353512001 ,, 000000000385712001 ,, 000000000385812001 ,, 000000000405512001 ,, 000000000406612001 ,, 000000000496312001 ,, 000000000503212001 ,, 000000000520312001 ,, 000000000546512001 ,, 000000000574812001 ,, 000000000587912001 ,, 000000000615712001 ,, 000000000623212001 ,, 000000000681112001 ,, 000000000709312001 ,, 000000000709412001 ,, 000000000712112001 ,, 000000000725312001 ,, 000000000726312001 ,, 000000000760512001 ,, 000000000792812001 ,, 000000000813012001 ,, 000000000848912001 ,, 000000000871612001 ,, 000000000959612001 ,, 000000001014212001 ,, 000000001132612001 ,, 000000001168512001 ,, 000000001196612001 ,, 000000001213712001 ,, 000000001235712001 ,, 000000001324112001 ,, 000000001341012001 ,, 000000001354912001 ,, 000000001362412001 ,, 000000001382112001 ,, 000000001384512001 ,, 000000001634612001 ,, 000000001634712001 ,, 000000001635012001 ,, 000000001645912001 ,, 000000001695412001 ,, 000000001705512001 ,, 000000001752412001 ,, 000000001782812001 ,, 000000001783612001 ,, 000000001804712001 ,, 000000001823412001 ,, 000000001850912001 ,, 000000001873512001 ,, 000000001882512001 ,, 000000001936612001 ,, 000000001938712001 ,, 000000001938812001 ,, 000000002045412001 ,, 000000002059512001 ,, 000000002104112001 ,, 000000002179412001 ,, 000000002240312001 ,, 000000002323212001 ,, 000000002346312001 ,, 000000002360212001 ,, 000000002368012001 ,, 000000002370912001 ,, 000000002371012001 ,, 000000002380812001 ,, 000000002401612001 ,, 000000002421712001 ,, 000000002422812001 ,, 000000002424312001 ,, 000000002433512001 ,, 000000002444812001 ,, 000000002508012001 ,, 000000002580412001 ,, 000000002610013001 ,, 000000002615112001 ,, 000000002662913001 ,, 000000002682613001 ,, 000000002705213001 ,, 000000002714613001 ,, 000000002788513001 ,, 000000002815713001 ,, 000000002967013001 ,, 000000002988213001 ,, 000000003009213001 ,, 000000003053413001 ,, 000000003059013001 ,, 000000003067613001 ,, 000000003071813001 ,, 000000003158813001 ,, 000000003223813001 ,, 000000003273213001 ,, 000000003286913001 ,, 000000003297813001 ,, 000000003300613001 ,, 000000003302213001 ,, 000000003332213001 ,, 000000003356613001 ,, 000000003379513001 ,, 000000003382713001 ,, 000000003409613001 ,, 000000003465613001 ,, 000000003489313001 ,, 000000003633013001 ,, 000000003633113001 ,, 000000003643713001 ; , 28) Model 22214C , CRANIAL N
Recalling Firm/
Manufacturer
Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
For Additional Information Contact Customer Hotline
800-5975911
Manufacturer Reason
for Recall
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
FDA Determined
Cause 2
Software in the Use Environment
Action The firm, Brainlab AG, sent out a "Field Safety Notice / Product Notification" CAPA-20130417-000315 Brainlab Cranial Navigation System: Effect of setup on overall navigation accuracy for all versions of software on 4/22/2013 and an update on 5/29/2015. - From April 22, 2013 has been distributed via email to the consignees. - UPDATE from May 29, 2015 was distributed via email to the medical users. An active reply by the consignees will be followed, if necessary via further different communication media. FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the measures described in document Measures to Improve Cranial Navigation Accuracy in the Product Notification letter when using the Brainlab Cranial Navigation System. Brainlab is requesting that 1. Existing potentially affected customers receive this Product Notification Letter. 2. These customers receive the attached supplement to the Instructions for Use regarding the Brainlab Cranial Navigation System in hardcopy version as an amendment to their current User Manuals. Tentative planned timeline for availability: June 2013 Additionally to advise the appropriate personnel working in your department of the content of Product Notification letter. If the medical users have the need for further clarification, they are asked to contact their local Brainlab Customer Support Representative. Customer Hotline: +49 89 99 15 68 44 or +1 800 597 5911 (for US customers) or by E-mail: support@brainlab.com. Fax Brainlab AG: + 49 89 99 15 68 33 Address: Brainlab AG (headquarters), Kapellenstrasse 12, 85622 Feldkirchen, Germany.
Quantity in Commerce 1,430 units
Distribution Worldwide Distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = BRAINLAB AG
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