Brainlab AG: Medical Device Recall in 2023 - (Recall #: Z-1259-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 14, 2023

Date Posted: March 22, 2023

Recall Number: Z-1259-2023

Event ID: 91664

Reason for Recall:

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Status: Ongoing

Product Quantity: 56 systems in the U.S.

Code Information:

Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated