Home / Recalls / Brainlab AG / Z-1392-2025

Z-1392-2025 Class II Ongoing

Recalled by Brainlab AG — Munich, N/A

Recall Details

Product Type
Devices
Report Date
March 26, 2025
Initiation Date
February 10, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1

Reason for Recall

Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

Distribution Pattern

Worldwide - US Nationwide distribution.

Code Information

Origin Data Management software version 3.1 is 04056481145118; Origin Data Management software version 3.2 is 04056481146078

Other recalls by Brainlab AG

  • 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-1185-2021 Class II — ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). (March 1, 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)