Home / Recalls / Brainlab AG / Z-2925-2020

Z-2925-2020 Class II Terminated

Recalled by Brainlab AG — Munich, N/A

Recall Details

Product Type
Devices
Report Date
September 9, 2020
Initiation Date
August 20, 2020
Termination Date
May 13, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21 arms

Product Description

Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)

Reason for Recall

Holding force of the Positioning Arm can be reduced by prolonged non-use.

Distribution Pattern

USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom

Code Information

Article Number: 56000-01B, Description: CIRQ ARM SYSTEM 1.3.2, Serial numbers: 20100132017 20100132019 20100132020 20100132022 20100132023 20100132026 20100132028 20100132030 20100132031 20100132033 20100132035 20100132036 20100132037 20100132038 20100132039 Article Number: 56000-01C, Description:CIRQ ARM SYSTEM 1.4, Serial numbers: 20100140052 20100140053 20100140054 20100140055 20100140056 20100140057

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-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-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)