Brainlab AG

Complete recall history across all FDA and CPSC categories — 39 total recalls

Brainlab AG appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (39)

FDA medical device enforcement actions by Brainlab AG

Date Product Reason Class
Feb 10, 2025 Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 Under certain circumstances, it can occur that patient records from unrelated... Class II
Mar 2, 2023 Cirq Arm System 2.0 Risk of mechanical instability due to potential manufacturing error of the de... Class II
Feb 14, 2023 Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therap... Deep Inspiration Breath Hold (DIBH) functionality may not work as specified w... Class II
Feb 25, 2022 ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Mon... The yaw angle may be incorrect for CBCT positioning workflows using setup bea... Class II
May 14, 2021 ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Ins... Display of potential patient movement might be delayed to the user for high d... Class II
Mar 1, 2021 ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). In case of a failed automatic marker detection, a software error causes parts... Class II
Aug 31, 2020 Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cr... Brainlab Ultrasound Navigation Software does not support the modification of ... Class II
Aug 20, 2020 Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56... Holding force of the Positioning Arm can be reduced by prolonged non-use. Class II
Jul 16, 2020 BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; ... Incorrect manufacturer calibration Class II
Jul 16, 2020 BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 U... Incorrect manufacturer calibration Class II
Sep 25, 2019 Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MAN... The Brainlab Patient Data Manager software (PDM) in combination with the Brai... Class II
Mar 11, 2019 RT Elements Software revisions of the RT Elements applications have a speci... There is a potential for an incorrect dose distribution calculation by Brainl... Class II
Feb 27, 2019 Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software ... In certain occurrences, the affected navigation software application might un... Class I
Feb 14, 2018 ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an... The usage of workflows that deviate from the recommended specifications in th... Class II
Nov 16, 2017 Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLin... Due to a human error at a supplier, an unknown number of devices within one s... Class II
Nov 3, 2017 BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 462... Brainlab has internally detected that under specific conditions ExacTrac Vero... Class II
Jul 28, 2017 AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is... Risk of unintended motion while the AIRO system is in transport mode. Class II
Oct 27, 2016 Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image ... Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Bas... Class II
May 4, 2016 ExacTrac Vero is a Patient Positioning System for Radiation therapy. Potentially incorrect positioning when using Implanted Marker Detection with ... Class II
Nov 5, 2015 RT Elements are applications for radiation treatment planning for use in ster... Large objects with fine resolution are potentially displayed cropped when imp... Class II
Nov 5, 2015 RT Elements are applications for radiation treatment planning for use in ster... Large objects with fine resolution are potentially displayed cropped when imp... Class II
Sep 21, 2015 Digital Lightbox, BrainLAB system, image processing, radiological Product ... Potentially incorrectly displayed objects when actively deselecting a fused r... Class II
Aug 18, 2015 Disposable Reflective Marker Spheres The Disposable Reflective Marker Sphe... Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery... Class II
Aug 5, 2015 ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to... ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Di... Class II
May 8, 2015 BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation... Instances of data sets not being accurately registered to the patient anatomy... Class II
Mar 6, 2015 ExacTrac 6.x. is software used to place patients at an accurately defined poi... ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positi... Class II
Feb 16, 2015 ExacTrac versions 6.x patient positioning systems are used to position patien... The ExacTrac 6.x Patient Positioning System may incorrectly position the pati... Class II
Jan 16, 2015 The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system.... The recommended sterilization and drying parameters are not effective to achi... Class II
Nov 19, 2014 iPlan RT Dose is a stereotactic radiation treatment planning system that is i... iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient... Class II
Nov 19, 2014 iPlan RT is a radiation treatment planning system that is intended for use in... iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient... Class II
Jun 27, 2014 Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Vi... The following defects have been identified for data loaded with Patient Data ... Class II
Jun 24, 2014 ExacTrac is intended to be used to place patients at an accurately defined po... When using multiple isocenters (radiation treatment targets) within a single ... Class II
May 21, 2014 Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intrao... Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic r... Class II
Apr 15, 2014 ExacTrac 5.5, an Image Processing System used for patient positioning for rad... When using a specific plan update workflow in combination with a non-Brainlab... Class II
Feb 24, 2014 ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalog... When using multiple radiation treatment targets within a single plan, the Exa... Class II
Nov 18, 2013 Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative imag... The "fluoro match registration" function of the Navigation Software Spine & T... Class II
Nov 15, 2013 BrainLAB's VectorVision spine is intended for use as an intraoperative image-... Brainlab has determined that pins of thee Instrument Star Unit ML (Calibratio... Class II
Jul 16, 2013 BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to com... The Frameless SRS QA Target Pointer - Pointer Cap with the engraved cross hai... Class II
Apr 22, 2013 Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereota... Software Error: The effect of setup on overall navigation accuracy could pote... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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