Z-1259-2023Class II

Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and...

Name: Z-1259-2023 Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and...
Creator: Brainlab AG
Published: 2023-02-14
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2023-02-14 / Open, Classified / root cause: software

FDA source

Brainlab AG began a recall of Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F on 2023-02-14. FDA classified it as Class II and gives the reason as "Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1259-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-03-16
Recalling firm: Brainlab, Inc.
Product: Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Root cause tag: software
FDA 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 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.
Product codes and lots: Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1259-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1259-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-16

Product code IYE

K220338Class IIExacTrac DynamicBrainlab AG / cleared 2022-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)