ExacTrac Dynamic recallZ-1259-2023 · Brainlab AG · initiated Feb 14, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1259-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 14, 2023
- Posted by the FDA
- Mar 16, 2023
- Recalling firm
- Brainlab AG
- Quantity
- 56 systems in the U.S.
- Product code
- IYE
- FDA submissions
- K220338
- 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.
Product description
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Code information (models, lots, serial numbers)
Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ExacTrac Dynamic 1.1Brainlab SE · Accelerator, Linear, Medical1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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