Home / Recalls / Brainlab AG / Z-1185-2021

Z-1185-2021 Class II Terminated

Recalled by Brainlab AG — Munich

Recall Details

Product Type
Devices
Report Date
March 17, 2021
Initiation Date
March 1, 2021
Termination Date
March 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed

Product Description

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

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.

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.

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.

Other recalls by Brainlab AG

  • Z-1392-2025 Class II — Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 (February 10, 2025)
  • Z-1292-2023 Class II — Cirq Arm System 2.0 (March 2, 2023)
  • Z-1259-2023 Class II — Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy S (February 14, 2023)
  • Z-0733-2022 Class II — ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. (February 25, 2022)
  • Z-1846-2021 Class II — ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Instal (May 14, 2021)
  • Z-0056-2021 Class II — Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Crani (August 31, 2020)
  • Z-2925-2020 Class II — Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000 (August 20, 2020)
  • Z-2792-2020 Class II — BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 199 (July 16, 2020)
  • Z-2793-2020 Class II — BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (July 16, 2020)
  • Z-0176-2020 Class II — Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGE (September 25, 2019)