Z-1185-2021Class II

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)

Name: Z-1185-2021 ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)
Creator: Brainlab AG
Published: 2021-03-01
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2021-03-01 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) on 2021-03-01. FDA classified it as Class II and gives the reason as "In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1185-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-01
Posted: 2021-03-08
Terminated: 2023-03-20
Recalling firm: Brainlab, Inc.
Product: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Product code: IYE Accelerator, Linear, Medical
Reason for recall: In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Root cause tag: software
FDA root cause: Software design
Action: The Field Safety Notice / Product Notification Letter CAPA-20210210-002387 was distributed via email on 03/01/2021. An active reply by the consignees will be followed, if necessary via further different communication media. For future customers/facilities/systems (new installations or updates/upgrades): As of February 23, 2021: - the Field Safety Notice / product notification information is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a confirmation is required that the contained User Corrective Actions will be implemented before clinical use by the facility (to be adhered to by the users).
Quantity in commerce: 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Distribution: USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
Product codes and lots: Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1185-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1185-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-08

Product code IYE

K201276Class IIExacTrac DynamicBrainlab AG / cleared 2020-07-13

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)