FDA Medical Device Recalls (openFDA)
Brainlab AG: Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
- Recall number
- Z-1259-2023
- Recalling firm
- Brainlab AG
- Product
- Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
- Status
- Open, Classified
- Initiated
- 2023-02-14
- Posted
- 2023-03-16
- Terminated
- not on file
- Reason
- Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
- 510(k) numbers
- ["K220338"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3002619595
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28