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U.S. Department of Health and Human Services

Class 2 Device Recall ExacTrac Dynamic

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  Class 2 Device Recall ExacTrac Dynamic see related information
Date Initiated by Firm February 14, 2023
Date Posted March 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-1259-2023
Recall Event ID 91664
510(K)Number K220338  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Code Information Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
Recalling Firm/
Brainlab AG
Olof-palme-str. 9
Munich Germany
Manufacturer Reason
for Recall
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
FDA Determined
Cause 2
Software design
Action The recalling firm issued letters dated 1/25/2023 via email and were flagged URGENT FIELD SAFETY NOTICE / PRODUCT NOTIFICATION. The letter provides the user information on how the issue occurs and informs them of the corrective actions Brainlab is taking to address the issue. Detailed information on the issue and its effects are provided. The letter provides User Corrective Actions: (1) Always create DIBH Treatment Templates from the Brainlab provided DIBH Master Templates; and (2) Always ensure that Beam Hold Control is enabled ("On") before proceeding to DIBH treatment. Brainlab will provide a software revision of ExacTrac Dynamic to all affected customers with the described issue corrected. Brainlab will actively contact the consignee to schedule the update starting April 2023. The consignee is to advise the appropriate personnel working in their department of the content of the letter. Consignee response to the letter was requested in the email. The response by the consignee was to include they have received the notification, the referenced device is installed at their hospital and they are the correct recipient for this communication, and the users at the hospital have been made aware of the content and to adhere to the User Corrective Action described in the notification.
Quantity in Commerce 56 systems in the U.S.
Distribution US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = Brainlab AG