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U.S. Department of Health and Human Services

Class 2 Device Recall Brainlab

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  Class 2 Device Recall Brainlab see related information
Date Initiated by Firm February 16, 2015
Date Posted March 25, 2015
Recall Status1 Terminated 3 on February 28, 2017
Recall Number Z-1316-2015
Recall Event ID 70657
510(K)Number K120789  
Product Classification Accelerator, linear, medical - Product Code IYE
Product ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Code Information ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0.   Model/Catalog Numbers:   49971, CBCT IMPORT & ALIGNMENT SOFTWARE;  20836, EXACTRAC 6.0 VARIAN CBCT LICENSE;   The software may be contained in configured items:   48320, ET UPGRADE SOFTWARE 6.0 TO 6.1;  48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA;  49973B, ET DATA PREP / REVIEW SYSTEM;  49973A, ET DATA PREP / REVIEW SYSTEM;  49973, ET DATA PREP / REVIEW SYSTEM;  49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;  48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT;  48302, ET DATA PREP / REVIEW SYSTEM
Recalling Firm/
Manufacturer		 Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
For Additional Information Contact Customer Hotline
800-5975911
Manufacturer Reason
for Recall		 The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
FDA Determined
Cause 2		 Software in the Use Environment
Action BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. Brainlab provided existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian TrueBeam system) with the product notification information. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customer starting August 2015 to schedule the update installation. For further questions please call Customer Hotline + 49 89 99 15 68 44 or 1-800 597-5911 ( For US Customers only)
Quantity in Commerce 24 systems (US); 36 systems (Foreign)
Distribution Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and 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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