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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac

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 Class 2 Recall
ExacTrac
see related information
Date Posted June 03, 2014
Recall Status1 Open
Recall Number Z-1707-2014
Recall Event ID 67926
Premarket Notification
510(K) Number
K072506 
Product Classification Accelerator, Linear, Medical - Product Code IYE
Product ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Code Information ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.5.5; 2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5; 3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5; 4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5; 5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5; 6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5; 7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5; 8) 49660A ET INFRARED SOFTWARE 5.5.5; 9) 49961 ET DATA PREP/REVIEW SYSTEM; 10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT; 11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT; 12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT; 13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT; 14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT; 15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT
Recalling Firm/
Manufacturer
Brainlab AG
Kapellenstrasse 12
Feldkirchen
For Additional Information Contact Brainlab Customer Support
800-5975911
Manufacturer Reason
for Recall
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
FDA Determined
Cause 2
DESIGN: Software Design
Action Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.
Quantity in Commerce 40 systems (worldwide)
Distribution Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = BRAINLAB AG
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