chicago_biz
9 records
Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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Chicago License: Brainlab, Inc.
Limited Business License | Provide Advertising or Marketing Services
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fda
35 records
FDA Device Recall: Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
2025-03-26
Class II — Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
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FDA Device Recall: Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy S
2023-03-22
Class II — Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
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FDA Device Recall: ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni.
2022-03-16
Class II — The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
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FDA Device Recall: ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Instal
2021-06-16
Class II — Display of potential patient movement might be delayed to the user for high dose treatments.
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FDA Recall: Brainlab AG — Class II
20201014
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. | Product: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT ...
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FDA Device Recall: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Crani
2020-10-14
Class II — Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
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FDA Device Recall: Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000
2020-09-09
Class II — Holding force of the Positioning Arm can be reduced by prolonged non-use.
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FDA Device Recall: BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI
2020-08-19
Class II — Incorrect manufacturer calibration
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FDA Device Recall: BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 199
2020-08-19
Class II — Incorrect manufacturer calibration
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FDA Recall: Brainlab AG — Class I
20190424
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal ( | Product: Spine & Trauma 3D Navigation 1.0 (subp...
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FDA Device Recall: Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGE
2019-10-30
Class II — The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in com...
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FDA Device Recall: Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spi
2019-04-24
Class I — In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed plan...
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FDA Recall: Brainlab AG — Class II
20180214
Risk of unintended motion while the AIRO system is in transport mode. | Product: AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used fo
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FDA Device Recall: ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an ac
2018-03-21
Class II — The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interf...
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FDA Device Recall: AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is in
2018-02-14
Class II — Risk of unintended motion while the AIRO system is in transport mode.
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FDA Device Recall: Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink R
2018-01-17
Class II — Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined s...
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FDA Device Recall: BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238
2017-12-06
Class II — Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shif...
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FDA Device Recall: Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Gui
2017-01-18
Class II — Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable fo...
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FDA Recall: Brainlab AG — Class II
20160615
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 | Product: ExacTrac Vero is a Patient Positioning System for Radiation therapy.
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FDA Recall: Brainlab AG — Class II
20160120
Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0 | Product: RT Elements are applications for radiation treatment p...
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FDA Device Recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy.
2016-06-15
Class II — Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
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FDA Device Recall: Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotacti
2016-01-27
Class I — Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cau...
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FDA Device Recall: RT Elements are applications for radiation treatment planning for use in stereot
2016-01-20
Class II — Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0
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FDA Device Recall: RT Elements are applications for radiation treatment planning for use in stereot
2016-01-20
Class II — Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
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FDA Recall: Brainlab AG — Class II
20150121
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. | Product: iPlan RT is a radiation treatment planning system...
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FDA Device Recall: Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres
2015-09-30
Class II — Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed togethe...
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FDA Device Recall: ExacTrac 6.x. is software used to place patients at an accurately defined point
2015-05-13
Class II — ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
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FDA Device Recall: ExacTrac versions 6.x patient positioning systems are used to position patients
2015-04-01
Class II — The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
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FDA Device Recall: The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system.
2015-03-04
Class II — The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
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FDA Device Recall: iPlan RT is a radiation treatment planning system that is intended for use in st
2015-01-21
Class II — iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
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FDA Recall: Brainlab AG — Class II
20140820
Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable au | Product: Navigation Spine & Trauma 3D Version 2...
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FDA Recall: Brainlab AG — Class II
20140806
The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) | Product: Patient Data Manager 2.0 (Content man...
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FDA Device Recall: Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoper
2014-08-20
Class II — Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requ...
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FDA Device Recall: Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewe
2014-08-06
Class II — The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image dat...
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FDA Device Recall: BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compen
2013-09-04
Class II — The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap.
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ny_corps
1 records
NY Corp: BRAINLAB, INC.
2011-03-25
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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