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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac Dynamic Software

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 Class 2 Device Recall ExacTrac Dynamic Softwaresee related information
Date Initiated by FirmMay 14, 2021
Create DateJune 10, 2021
Recall Status1 Terminated 3 on March 20, 2023
Recall NumberZ-1846-2021
Recall Event ID 87984
510(K)NumberK203173 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Code Information Version 1.02, GTIN 04056481142315
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall		Display of potential patient movement might be delayed to the user for high dose treatments.
FDA Determined
Cause 2		Software design
ActionAn Urgent Field Safety Notice/Product Notification dated 4/29/2021 was issued on 5/14/2021 via email explaining the safety issue and letting the customer know that this issue is in addition to the previous notification of 9/8/2020 which has now expanded to versions 1.0.1 and 1.0.2.
Quantity in Commerce22 systems in the U.S.
DistributionUS Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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