Brainlab Ag recalls
Brainlab Ag appears in 39 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 39 |
|---|---|
| Published | 2013-09-04 to 2025-03-26 |
| By agency | FDA Device (39) |
| By classification | Class II (37), Class I (2) |
| By status | terminated (35), ongoing (4) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WY |
Recalls
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA Device · Class II · 2025-03-26 · Brainlab Ag
Reason: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification. - Cirq Arm System 2.0
FDA Device · Class II · 2023-04-05 · Brainlab Ag
Reason: Risk of mechanical instability due to potential manufacturing error of the device - Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F
FDA Device · Class II · 2023-03-22 · Brainlab Ag
Reason: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template - ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
FDA Device · Class II · 2022-03-16 · Brainlab Ag
Reason: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. - ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at…
FDA Device · Class II · 2021-06-16 · Brainlab Ag
Reason: Display of potential patient movement might be delayed to the user for high dose treatments. - ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)
FDA Device · Class II · 2021-03-17 · Brainlab Ag
Reason: In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to… - Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended…
FDA Device · Class II · 2020-10-14 · Brainlab Ag
Reason: Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. - 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)
FDA Device · Class II · 2020-09-09 · Brainlab Ag
Reason: Holding force of the Positioning Arm can be reduced by prolonged non-use. - BRAINLAB Kick 2
FDA Device · Class II · 2020-08-19 · Brainlab Ag
Reason: Incorrect manufacturer calibration - BRAINLAB Curve
FDA Device · Class II · 2020-08-19 · Brainlab Ag
Reason: Incorrect manufacturer calibration - Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICE…
FDA Device · Class II · 2019-10-30 · Brainlab Ag
Reason: 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 combination with iPlan CMF/Crania… - RT Elements Software revisions of the RT Elements applications have a specific software version number
FDA Device · Class II · 2019-05-01 · Brainlab Ag
Reason: There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card),… - Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Traum…
FDA Device · Class I · 2019-04-24 · Brainlab Ag
Reason: In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstructio… - 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 medic…
FDA Device · Class II · 2018-03-21 · Brainlab Ag
Reason: 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 Interface (ADI) and Varian Clinac or… - AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications fo…
FDA Device · Class II · 2018-02-14 · Brainlab Ag
Reason: Risk of unintended motion while the AIRO system is in transport mode. - Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
FDA Device · Class II · 2018-01-17 · Brainlab Ag
Reason: 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 specifications. - BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3…
FDA Device · Class II · 2017-12-06 · Brainlab Ag
Reason: 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 shift. This may result in the trea… - Femoral and Tibial Cutting Block Adapter Base
FDA Device · Class II · 2017-01-18 · Brainlab Ag
Reason: 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 for reprocessing - ExacTrac Vero is a Patient Positioning System for Radiation therapy
FDA Device · Class II · 2016-06-15 · Brainlab Ag
Reason: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 - Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic
FDA Device · Class I · 2016-01-27 · Brainlab Ag
Reason: 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 cause an inaccurate display of i… - RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation t…
FDA Device · Class II · 2016-01-20 · Brainlab Ag
Reason: Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0. - RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation t…
FDA Device · Class II · 2016-01-20 · Brainlab Ag
Reason: Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0 - BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D ve…
FDA Device · Class II · 2015-11-25 · Brainlab Ag
Reason: Instances of data sets not being accurately registered to the patient anatomy were observed. - Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the disp…
FDA Device · Class II · 2015-11-11 · Brainlab Ag
Reason: Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. - Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting…
FDA Device · Class II · 2015-09-30 · Brainlab Ag
Reason: 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 together. - ExacTrac 6.0.x Patient Positioning System, Radiation therapy
FDA Device · Class II · 2015-09-02 · Brainlab Ag
Reason: ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification. - ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for ster…
FDA Device · Class II · 2015-05-13 · Brainlab Ag
Reason: 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. - ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures
FDA Device · Class II · 2015-04-01 · Brainlab Ag
Reason: 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. - The Brainlab Offset Cup Impactor Universal
FDA Device · Class II · 2015-03-04 · Brainlab Ag
Reason: The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. - iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned,…
FDA Device · Class II · 2015-01-21 · Brainlab Ag
Reason: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. - iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiat…
FDA Device · Class II · 2015-01-21 · Brainlab Ag
Reason: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets. - Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally inva…
FDA Device · Class II · 2014-08-20 · Brainlab Ag
Reason: 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 requires the gantry position of th… - ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for ste…
FDA Device · Class II · 2014-08-13 · Brainlab Ag
Reason: When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green… - Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox
FDA Device · Class II · 2014-08-06 · Brainlab Ag
Reason: 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 data with PDM 2.0, the data set is… - ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery
FDA Device · Class II · 2014-06-11 · Brainlab Ag
Reason: When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of… - ExacTrac 6.0 is a patient positioning and monitoring system
FDA Device · Class II · 2014-05-07 · Brainlab Ag
Reason: When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation tr… - Brainlab, Spine & Trauma 3D 2.0, Navigation Software
FDA Device · Class II · 2014-04-23 · Brainlab Ag
Reason: The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used… - BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery
FDA Device · Class II · 2014-02-19 · Brainlab Ag
Reason: Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection an… - BRAINLAB
FDA Device · Class II · 2013-09-04 · Brainlab Ag
Reason: 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.