Brainlab AG
Medical device manufacturer in Munich, DE.
143510(k) clearances
0PMA approvals
46recalls
Device types
- HAW Neurological Stereotaxic Instrument 59
- IYE Accelerator, Linear, Medical 23
- OLO Orthopedic Stereotaxic Instrument 21
- LLZ System, Image Processing, Radiological 14
- MUJ System, Planning, Radiation Therapy Treatment 11
- LHN System, Radiation Therapy, Charged-Particle… 3
- QIH Automated Radiological Image Processing… 3
- JAI Couch, Radiation Therapy, Powered 2
- KXK Source, Brachytherapy, Radionuclide 1
- JAK System, X-Ray, Tomography, Computed 1
- HBL Holder, Head, Neurosurgical (Skull Clamp) 1
- QQC Brain Stimulation Programming Planning… 1
- PGW Ear, Nose, And Throat Stereotaxic Instrument 1
- SBF Orthopedic Augmented Reality 1
- OWB Interventional Fluoroscopic X-Ray System 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceIYE · Special | 01/14/2026SE |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…LLZ · Special | 10/16/2025SE |
| K252562 | Spine & Trauma Navigation InstrumentsOLO · Special | 09/12/2025SE |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PADOWB · Traditional | 07/22/2025SE |
| K243142 | Cranial 4Pi ImmobilizationIYE · Traditional | 06/23/2025SE |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…MUJ · Traditional | 06/17/2025SE |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…QIH · Traditional | 06/13/2025SE |
| K243810 | TraumaCad Neo (1.1)QIH · Traditional | 06/04/2025SE |
| K242569 | Mixed Reality Spine NavigationSBF · Traditional | 05/16/2025SE |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…HAW · Traditional | 01/28/2025SE |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceIYE · Traditional | 07/24/2024SE |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma NavigationOLO · Special | 05/23/2024SE |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…LLZ · Traditional | 05/21/2024SE |
| K234047 | Automatic RegistrationOLO · Traditional | 03/20/2024SE |
| K231498 | TraumaCad NeoLLZ · Traditional | 11/20/2023SE |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…HAW · Traditional | 09/09/2023SE |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineOLO · Traditional | 08/02/2023SE |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…HAW · Traditional | 07/21/2023SE |
| K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…QIH · Traditional | 07/14/2023SE |
| K231052 | ExacTrac Dynamic 1.1.2IYE · Special | 05/11/2023SE |
| K223734 | ENT EmPGW · Traditional | 04/27/2023SE |
| K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…HAW · Traditional | 04/19/2023SE |
| K223279 | RT Elements (4.0)MUJ · Traditional | 03/14/2023SE |
| K222966 | Cirq Arm System (2.0);Alignment System SpineOLO · Special | 10/27/2022SE |
| K213989 | Cranial EM SystemHAW · Traditional | 09/08/2022SE |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…OLO · Traditional | 08/30/2022SE |
| K220652 | Knee 3OLO · Traditional | 06/03/2022SE |
| K220338 | ExacTrac DynamicIYE · Traditional | 04/29/2022SE |
| K213930 | Brainlab Elements Guide XT, Guide 3.0QQC · Traditional | 04/19/2022SE |
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…OLO · Traditional | 04/13/2022SE |
| K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…LLZ · Traditional | 12/16/2021SE |
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…HAW · Traditional | 11/12/2021SE |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationHAW · Traditional | 11/03/2021SE |
| K211939 | ExacTrac DynamicIYE · Special | 07/22/2021SE |
| K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…MUJ · Traditional | 04/09/2021SE |
| K203679 | Automatic RegistrationOLO · Special | 03/18/2021SE |
| K201752 | Disposable Pre-calibrated SuctionHAW · Traditional | 01/29/2021SE |
| K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…OLO · Traditional | 12/23/2020SE |
| K203173 | ExacTrac DynamicIYE · Special | 11/12/2020SE |
| K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…HAW · Traditional | 10/08/2020SE |
| K202050 | Cranial 4Pi ImmobilizationIYE · Special | 08/19/2020SE |
| K201276 | ExacTrac DynamicIYE · Traditional | 07/13/2020SE |
| K193307 | HIP7OLO · Traditional | 06/02/2020SE |
| K191014 | Elements ViewerLLZ · Traditional | 01/23/2020SE |
| K190250 | Microscope NavigationHAW · Special | 09/06/2019SE |
| K183605 | Spine & Trauma NavigationOLO · Traditional | 08/29/2019SE |
| K191285 | Spine & Trauma NavigationOLO · Special | 06/11/2019SE |
| K190042 | Brainlab Elements Image Fusion AngioLLZ · Traditional | 04/25/2019SE |
| K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…MUJ · Special | 04/12/2019SE |
| K172820 | Microscope Navigation SoftwareHAW · Traditional | 03/01/2018SE |
| K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…LLZ · Traditional | 09/26/2017SE |
| K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…MUJ · Traditional | 08/24/2017SE |
| K153653 | DICOM ViewerLLZ · Traditional | 04/13/2016SE |
| K142108 | RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisMUJ · Traditional | 12/16/2014SE |
| K141199 | Quentry Dose ReviewLLZ · Traditional | 06/20/2014SE |
| K132763 | Advanced ViewerLLZ · Traditional | 02/28/2014SE |
| K122225 | Sterile Radiolucent Skull PinsHBL · Traditional | 04/26/2013SE |
| K122011 | Navigation Software Hip-Universal; Navigation Software Hip Thr-AesculapOLO · Traditional | 11/15/2012SE |
| K122451 | Exactrac VeroIYE · Traditional | 09/28/2012SE |
| K120789 | Exactrac X-Ray X-RayIYE · Traditional | 08/14/2012SE |
| K120520 | Exactrac Robotics Novalis RoboticsJAI · Traditional | 06/29/2012SE |
| K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan ENT, Iplan CMF, Iplan View, Iplan Spine)JAK · Traditional | 05/07/2012SE |
| K110021 | Dash HipOLO · Traditional | 10/18/2011SE |
| K110204 | Brainlab TraumaOLO · Traditional | 08/05/2011SE |
| K101627 | IplanHAW · Traditional | 06/03/2011SE |
| K102251 | Dash KneeOLO · Special | 05/17/2011SE |
| K102990 | Brainlab KneeOLO · Special | 04/04/2011SE |
| K103246 | Iplan RTMUJ · Traditional | 03/16/2011SE |
| K100038 | Disposable Reflective Marker SpheresHAW · Traditional | 07/14/2010SE |
| K093118 | Brainlab Knee ArthroscopyOLO · Traditional | 06/11/2010SE |
| K092467 | Vectorvision Cranial, Vectorvision ENT, Kolibri Cranial, Kolibri ENT, Cranial Essential…HAW · Special | 05/06/2010SE |
| K093117 | Digital LightboxLLZ · Traditional | 12/11/2009SE |
| K082060 | Cranial Image Guided Surgery SystemHAW · Traditional | 05/08/2009SE |
| K083483 | Brainlab Hip Unlimited, Ci Hip UnlimitedOLO · Traditional | 04/08/2009SE |
| K083310 | Spine & Trauma IctOLO · Special | 04/01/2009SE |
| K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited Ci Knee, Ci Knee UnlimitedHAW · Traditional | 09/05/2008SE |
| K080886 | Iplan RT ImageLHN · Traditional | 06/24/2008SE |
| K080888 | Modeification to Iplan RT DoseMUJ · Special | 06/11/2008SE |
| K080678 | Uni-Knee 2.0HAW · Traditional | 06/06/2008SE |
| K080608 | Digital LightboxLLZ · Traditional | 04/17/2008SE |
| K073018 | Stereotactic Target Positioner, Target Positioner for Leksell Headring, Stereotactic…IYE · Traditional | 01/23/2008SE |
| K072506 | Exactrac 5.5IYE · Traditional | 10/26/2007SE |
| K072046 | Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemIYE · Traditional | 10/17/2007SE |
| K072716 | Vector Vision HipHAW · Special | 10/12/2007SE |
| K072573 | Vectorvision Hip and Hip SRHAW · Special | 10/11/2007SE |
| K070556 | Brainsuite NetHAW · Traditional | 09/25/2007SE |
| K070106 | VV Fluoro 3DHAW · Traditional | 04/23/2007SE |
| K062358 | Modification to Vectorvision TraumaHAW · Special | 01/17/2007SE |
| K063028 | Vectorvision Hip SRHAW · Traditional | 12/12/2006SE |
| K062086 | NavivisionHAW · Traditional | 09/20/2006SE |
| K060727 | Vectorvision HipHAW · Special | 08/21/2006SE |
| K053584 | Iplan RT DoseMUJ · Special | 07/12/2006SE |
| K053159 | Vectorvision SpineHAW · Traditional | 06/06/2006SE |
| K053164 | Iplan FlowHAW · Traditional | 03/23/2006SE |
| K060468 | Vectorvision HipHAW · Special | 03/20/2006SE |
| K052966 | Ci Knee, Ci Mi TKRHAW · Traditional | 02/13/2006SE |
| K053127 | IplanHAW · Traditional | 02/09/2006SE |
| K053500 | Frameless Radiosurgery ComponentsIYE · Traditional | 02/03/2006SE |
| K052213 | Navigation SW Hip 3.1 on CiHAW · Special | 11/02/2005SE |
| K052220 | Iplan RT FibertrackingIYE · Traditional | 09/30/2005SE |
| K042543 | Iplan! Digital TemplatingHAW · Traditional | 05/17/2005SE |
| K042721 | Kolibri SpineHAW · Traditional | 04/19/2005SE |
| K042513 | Vectorvision OsteotomyHAW · Traditional | 02/10/2005SE |
| K042512 | Vectorvision AclHAW · Traditional | 01/13/2005SE |
| K041703 | Iplan!HAW · Traditional | 10/22/2004SE |
| K042391 | Kolibri Image Guided Surgery SystemHAW · Traditional | 10/19/2004SE |
| K041899 | Vectorvision Uni-KneeHAW · Special | 10/06/2004SE |
| K041330 | Iplan! FlowHAW · Traditional | 09/22/2004SE |
| K040368 | Vectorvision Hip 3.0HAW · Traditional | 08/23/2004SE |
| K040931 | Patxfer RTLLZ · Traditional | 07/22/2004SE |
| K033316 | Table Tilt DeviceJAI · Traditional | 05/14/2004SE |
| K040585 | Exactrac 4.0 and Exactrac X-Ray 6DIYE · Traditional | 05/11/2004SE |
| K023651 | Vectorvision Cranial/EntHAW · Traditional | 02/17/2004SE |
| K032511 | Intuition ImageLHN · Traditional | 01/21/2004SE |
| K033287 | Exactrac GatingIYE · Traditional | 12/19/2003SE |
| K031770 | Ci Tkr/UkrHAW · Traditional | 08/12/2003SE |
| K024192 | Vectorvision FLUORO3DHAW · Traditional | 06/11/2003SE |
| K021306 | Vectorvision Ct-Free KneeHAW · Traditional | 10/25/2002SE |
| K020631 | IplanHAW · Traditional | 09/09/2002SE |
| K021583 | PatxferLLZ · Traditional | 08/12/2002SE |
| K014256 | Kolibri Igs SystemsHAW · Traditional | 07/19/2002SE |
| K020860 | M3 (Micro-Multileaf Collimator)IYE · Traditional | 06/06/2002SE |
| K004022 | M3 (Mirco-Multileaf CollimatorIYE · Traditional | 03/26/2002SE |
| K012448 | Vectorvision TraumaHAW · Traditional | 03/14/2002SE |
| K010602 | Vectorvision HipHAW · Traditional | 09/12/2001SE |
| K012564 | Modification to: Vectorvision Frameless Biopsy SystemHAW · Special | 09/06/2001SE |
| K010612 | Vectorvision KneeHAW · Traditional | 09/06/2001SE |
| K010968 | Vectorvision Ct/FluoroHAW · Traditional | 08/30/2001SE |
| K003285 | Exac Trac 2.0 (Novalis Body Module)IYE · Traditional | 07/31/2001SE |
| K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision ENTHAW · Traditional | 05/21/2001SE |
| K003268 | Z-TouchHAW · Traditional | 02/22/2001SE |
| K002509 | Novalis (Shaped Beam Surgery System)MUJ · Traditional | 11/03/2000SE |
| K994413 | BrainscanMUJ · Traditional | 07/13/2000SE |
| K992916 | Brainlab Stereotactic ArcHAW · Traditional | 01/11/2000SE |
| K983410 | @ TargetHAW · Traditional | 09/17/1999SE |
| K983660 | Exactrac (Brainlab Patient Positioning System)LHN · Traditional | 07/14/1999SE |
| K983831 | VECTORVISION2HAW · Traditional | 05/19/1999SE |
| K981508 | Vectorvision Spine ModuleHAW · Traditional | 10/29/1998SE |
| K971367 | Brainscan Conformal RT ModuleIYE · Traditional | 10/27/1997SE |
| K962939 | VectorvisionHAW · Traditional | 05/22/1997SE |
| K954789 | Brainlab HeadpinsHAW · Traditional | 08/12/1996SE |
| K920880 | Brainscan Brachytherapy ModuleKXK · Traditional | 12/30/1992SE |
| K920879 | Brainscan Radiosurgery ModuleIYE · Traditional | 12/29/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1392-2025 Class II | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1Under certain circumstances, it can occur that patient records from unrelated individuals are automatically… | 02/10/2025Open, Classified |
| Z-1292-2023 Class II | Cirq Arm System 2.0Risk of mechanical instability due to potential manufacturing error of the device | 03/02/2023Open, Classified |
| Z-1259-2023 Class II | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System…Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a… | 02/14/2023Open, Classified |
| Z-0733-2022 Class II | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST…The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | 02/25/2022Open, Classified |
| Z-1846-2021 Class II | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer…Display of potential patient movement might be delayed to the user for high dose treatments. | 05/14/2021Terminated |
| Z-1185-2021 Class II | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly… | 03/01/2021Terminated |
| Z-0056-2021 Class II | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT…Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. | 08/31/2020Terminated |
| Z-2925-2020 Class II | Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of…Holding force of the Positioning Arm can be reduced by prolonged non-use. | 08/20/2020Terminated |
| Z-2793-2020 Class II | BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for…Incorrect manufacturer calibration | 07/16/2020Terminated |
| Z-2792-2020 Class II | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905…Incorrect manufacturer calibration | 07/16/2020Terminated |
| Z-0176-2020 Class II | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER…The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan… | 09/25/2019Terminated |
| Z-1205-2019 Class II | RT Elements Software revisions of the RT Elements applications have a specific software…There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for… | 03/11/2019Terminated |
| Z-1082-2019 Class I | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine &…In certain occurrences, the affected navigation software application might unexpectedly display a navigated… | 02/27/2019Terminated |
| Z-1006-2018 Class II | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately…The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac… | 02/14/2018Terminated |
| Z-0320-2018 Class II | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink…Due to a human error at a supplier, an unknown number of devices within one specific production lot of… | 11/16/2017Terminated |
| Z-0172-2018 Class II | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC…Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for… | 11/03/2017Terminated |
| Z-0509-2018 Class II | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be…Risk of unintended motion while the AIRO system is in transport mode. | 07/28/2017Terminated |
| Z-0959-2017 Class II | Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided…Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers… | 10/27/2016Terminated |
| Z-1929-2016 Class II | ExacTrac Vero is a Patient Positioning System for Radiation therapy.Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 | 05/04/2016Terminated |
| Z-0648-2016 Class II | RT Elements are applications for radiation treatment planning for use in stereotactic…Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid… | 11/05/2015Terminated |
| Z-0647-2016 Class II | RT Elements are applications for radiation treatment planning for use in stereotactic…Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain… | 11/05/2015Terminated |
| Z-0218-2016 Class II | Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The…Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. | 09/21/2015Terminated |
| Z-2795-2015 Class II | Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in…Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres… | 08/18/2015Terminated |
| Z-2440-2015 Class II | ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to…ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph… | 08/05/2015Terminated |
| Z-0282-2016 Class II | BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software…Instances of data sets not being accurately registered to the patient anatomy were observed. | 05/08/2015Terminated |
| Z-1582-2015 Class II | ExacTrac 6.x. is software used to place patients at an accurately defined point within…ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac… | 03/06/2015Terminated |
| Z-1316-2015 Class II | ExacTrac versions 6.x patient positioning systems are used to position patients during…The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac… | 02/16/2015Terminated |
| Z-1215-2015 Class II | The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An…The recommended sterilization and drying parameters are not effective to achieve the minimum required… | 01/16/2015Terminated |
| Z-0957-2015 Class II | iPlan RT is a radiation treatment planning system that is intended for use in…iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using… | 11/19/2014Terminated |
| Z-0956-2015 Class II | iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for…iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using… | 11/19/2014Terminated |
| Z-2134-2014 Class II | Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0)…The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including… | 06/27/2014Terminated |
| Z-2146-2014 Class II | ExacTrac is intended to be used to place patients at an accurately defined point within…When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow… | 06/24/2014Terminated |
| Z-2213-2014 Class II | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative…Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively… | 05/21/2014Terminated |
| Z-1707-2014 Class II | ExacTrac 5.5, an Image Processing System used for patient positioning for radiation…When using a specific plan update workflow in combination with a non-Brainlab treatment planning system… | 04/15/2014Terminated |
| Z-1513-2014 Class II | ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers:…When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position… | 02/24/2014Terminated |
| Z-1469-2014 Class II | Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided…The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to… | 11/18/2013Terminated |
| Z-0967-2014 Class II | BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided…Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific… | 11/15/2013Terminated |
| Z-2083-2013 Class II | BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate…The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when… | 07/16/2013Terminated |
| Z-0598-2016 Class I | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic.…Software Error: The effect of setup on overall navigation accuracy could potentially intensify small… | 04/22/2013Terminated |
| Z-2251-2009 | BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery…Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software… | 08/12/2009Terminated |
| Z-1547-2009 | BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |
| Z-1546-2009 | BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |
| Z-1545-2009 | BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |
| Z-1544-2009 | BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622…The Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended… | 03/19/2009Terminated |
| Z-2209-2008 | VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is…Diameter of cables used for installation are to small for the applied current. If an internal short circuit… | 11/12/2007Terminated |
| Z-1010-2007 | BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions…Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of… | 06/05/2007Terminated |