Brainlab AG: Medical Device Recall in 2021 - (Recall #: Z-1185-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

Product Classification:

Class II

Date Initiated: March 1, 2021

Date Posted: March 17, 2021

Recall Number: Z-1185-2021

Event ID: 87395

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.

Status: Terminated

Product Quantity: 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated