Brainlab AG Olof-palme-str. 9 Munich Germany Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Recommended Action

Per FDA guidance

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.