Home / Recalls / Brainlab AG / Z-1292-2023

Z-1292-2023 Class II Ongoing

Recalled by Brainlab AG — Munich, N/A

Recall Details

Product Type
Devices
Report Date
April 5, 2023
Initiation Date
March 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

Cirq Arm System 2.0

Reason for Recall

Risk of mechanical instability due to potential manufacturing error of the device

Distribution Pattern

Texas

Code Information

56500 CIRQ ARM SYSTEM 2.0; GTIN 04056481143961; All available Serial numbers/lot numbers are affected.

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-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)