Brainlab AG: Medical Device Recall in 2021 - (Recall #: Z-1846-2021)

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 software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.

Product Classification:

Class II

Date Initiated: May 14, 2021

Date Posted: June 16, 2021

Recall Number: Z-1846-2021

Event ID: 87984

Reason for Recall:

Display of potential patient movement might be delayed to the user for high dose treatments.

Status: Terminated

Product Quantity: 22 systems in the U.S.

Code Information:

Version 1.02, GTIN 04056481142315

Distribution Pattern:

US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated