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U.S. Department of Health and Human Services

Class 2 Device Recall Brainlab ExacTrac 6.x Patient Positioning System

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  Class 2 Device Recall Brainlab ExacTrac 6.x Patient Positioning System see related information
Date Initiated by Firm March 06, 2015
Date Posted May 06, 2015
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-1582-2015
Recall Event ID 70951
510(K)Number K120789  
Product Classification Generator, dermatological (grenz ray), therapeutic x-ray - Product Code IYH
Product ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Code Information Software Versions: ExacTrac v. 6.x (v. 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;  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 Brainlab Customer Support
800-5975911
Manufacturer Reason
for Recall		 ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
FDA Determined
Cause 2		 Software in the Use Environment
Action FIELD SAFETY / PRODUCT NOTIFICATION letters dated March 6, 2015 were sent to all customers of record. The letters included instructions for customers to: 1) With immediate effect, always make sure the couch is at exactly 0.0 degrees (displayed on the Varian monitor) when acquiring a CBCT set to import into the ExacTrac software; 2) For Varian systems providing an option to prevent a CBCT acquisition for couch angles other than 0.0 degrees, Brainlab recommends selecting that option for use in combination with ExacTrac; and, 3) Continue to verify any ExacTrac CBCT based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. The letters further advised that Brainlab will be taking the following actions: 1. Brainlab provides existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian C-Series linac) with this product notification information; and, 2. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customers starting August 2015 to schedule the update installation. Customers with questions about this issue were advised to contact Brainlab at 800-597-5911 or via e-mail by writing at us.support@brainlab.com.
Quantity in Commerce 25 systems (US only); 53 systems (Foreign)
Distribution *** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
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 = IYH and Original Applicant = BRAINLAB AG
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