Home / Recalls / Brainlab AG / Z-2793-2020

Z-2793-2020 Class II Terminated

Recalled by Brainlab AG — Munich, N/A

Recall Details

Product Type
Devices
Report Date
August 19, 2020
Initiation Date
July 16, 2020
Termination Date
July 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 unit

Product Description

BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

Reason for Recall

Incorrect manufacturer calibration

Distribution Pattern

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

Code Information

KICK 2 NAVIGATION STATION, Serial Numbers: 0164217001-18170, S/N of affected NDI Camera: P7-12520 2703119001-18170, S/N of affected NDI Camera:P7-20938 2933119001-18170, S/N of affected NDI Camera:P7-21378 6171619001-18170, S/N of affected NDI Camera:P7-18830 8745417001-18170, S/N of affected NDI Camera:P7-15162 9178819001-18170, S/N of affected NDI Camera:P7-16025 9607118001-18170, S/N of affected NDI Camera:P7-13227 5469918001-18170, S/N of affected NDI Camera: P7-14965 KICK NAVIGATION STATION, Serial Number: 1190017001-18070, S/N of affected NDI Camera: P7-06110

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-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-0176-2020 Class II — Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGE (September 25, 2019)