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U.S. Department of Health and Human Services

Class 2 Device Recall Brainlab ExacTrac

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  Class 2 Device Recall Brainlab ExacTrac see related information
Date Initiated by Firm June 24, 2014
Date Posted August 04, 2014
Recall Status1 Terminated 3 on April 24, 2017
Recall Number Z-2146-2014
Recall Event ID 68741
510(K)Number K120789  
Product Classification Brainlab ExacTrac - Product Code IYE
Product ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Code Information ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE;  2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE;  3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE;  4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE;  5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR);  6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR);  7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR);  8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED;  9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC;  10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4;  11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4;  12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R;  13) 49973B ET DATA PREP / REVIEW SYSTEM;  14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY;  15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED;  16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
Recalling Firm/
Manufacturer
Brainlab AG
Kapellenstrasse 12
Feldkirchen Germany
For Additional Information Contact
800-5975911
Manufacturer Reason
for Recall
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
FDA Determined
Cause 2
Software design
Action Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated June 24, 2014, to all affected customers. The letter included instructions for customers to: 1) Avoid using plans with multiple isocenters in ExacTrac 6.0.4 whenever possible, and 2) If plans with multiple isocenters cannot be avoided and such a plan is used in ExacTrac v.6.0.4, then always select "Yes" in the dialog displayed to "keep the previous correction shift" when switching between isocenters and always verify all final treatment positions. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact you to schedule the update within the next 6 months. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.
Quantity in Commerce 15 systems
Distribution Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
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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