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All Recalls

Every Brainlab Ag Recall

Sorted by most recent. Click any recall for full details.

27 recalls
High RiskFDA
Brainlab Ag
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Medical Devices·0 affected·Feb 10, 2025
High RiskFDA
Brainlab Ag
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Medical Devices·56 affected·Feb 14, 2023
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 I...
Medical Devices·205 affected·Feb 25, 2022
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients ...
Medical Devices·22 affected·May 14, 2021
High RiskFDA
Brainlab Ag
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: inten...
Medical Devices·271 affected·Aug 31, 2020
High RiskFDA
Brainlab Ag
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)
Medical Devices·21 affected·Aug 20, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Medical Devices·9 affected·Jul 16, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Medical Devices·18 affected·Jul 16, 2020
High RiskFDA
Brainlab Ag
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2....
Medical Devices·1,230 affected·Sep 25, 2019
CriticalFDA
Brainlab Ag
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine ...
Medical Devices·148 affected·Feb 27, 2019
High RiskFDA
Brainlab Ag
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a med...
Medical Devices·587 affected·Feb 14, 2018
High RiskFDA
Brainlab Ag
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Medical Devices·80 affected·Nov 16, 2017
High RiskFDA
Brainlab Ag
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 T...
Medical Devices·28 affected·Nov 3, 2017
High RiskFDA
Brainlab Ag
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applicati...
Medical Devices·102 affected·Jul 28, 2017
High RiskFDA
Brainlab Ag
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Medical Devices·29 affected·Oct 27, 2016
High RiskFDA
Brainlab Ag
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Medical Devices·27 affected·May 4, 2016
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices·48 affected·Nov 5, 2015
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices·20 affected·Nov 5, 2015
High RiskFDA
Brainlab Ag
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consis...
Surgical Devices·28 affected·Aug 18, 2015
High RiskFDA
Brainlab Ag
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for st...
Medical Devices·25 affected·Mar 6, 2015
High RiskFDA
Brainlab Ag
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Medical Devices·24 affected·Feb 16, 2015
High RiskFDA
Brainlab Ag
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to ena...
Medical Devices·114 affected·Jan 16, 2015
High RiskFDA
Brainlab Ag
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radi...
Medical Devices·1,412 affected·Nov 19, 2014
High RiskFDA
Brainlab Ag
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the dis...
Medical Devices·154 affected·Jun 27, 2014
High RiskFDA
Brainlab Ag
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimall...
Medical Devices·17 affected·May 21, 2014
High RiskFDA
Brainlab Ag
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in ...
Medical Devices·6 affected·Jul 16, 2013
CriticalFDA
Brainlab Ag
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS Sys...
Medical Devices·2,528 affected·Apr 22, 2013