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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac 6.0

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  Class 2 Device Recall ExacTrac 6.0 see related information
Date Initiated by Firm February 24, 2014
Date Posted April 25, 2014
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-1513-2014
Recall Event ID 67719
510(K)Number K120789  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ExacTrac 6.0 is a patient positioning and monitoring system.

Model/catalogue numbers:
20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE
49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3
49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)
49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC
49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)
49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)
49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED
49973B ET DATA PREP / REVIEW SYSTEM
49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY
49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
Code Information ExacTrac version v.6.0.3.
Recalling Firm/
Manufacturer		 Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
For Additional Information Contact Brainlab Customer Support
800-9575911
Manufacturer Reason
for Recall		 When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
FDA Determined
Cause 2		 Software design
Action A FIELD SAFETY NOTICE / PRODUCT INFORMATION letters, dated February 24, 2014, were sent to all direct accounts. The letter identified the affected product, the reason for the recall, and included instructions for direct accounts to take while a permanent fix can be deployed. The letter also advised that a software update will be made available starting the end of April 2014. Customers with questions or concerns can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.
Quantity in Commerce 41 systems (13 systems in US; 28 systems to foreign countries)
Distribution Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
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 = IYE and Original Applicant = BRAINLAB AG
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