Brainlab AG
Country not established FDA
Brainlab AG is a medical device manufacturer, with 132 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II) and 47 FDA recalls as of 12 Nov 2026.
- Devices
- 132
- Registrations
- FDA
- FDA recalls
- 474 ongoing
Registry facts
- Registries
- FDA 510(k) 132
- EUDAMED 1
- FDA GUDID 1
- Device classes
- FDA Class II 132
- FDA recalls
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Brainlab AG makes
Brainlab AG manufactures robotic surgical navigation systems for precision-guided procedures, including electromagnetic and optical tracking devices for intraoperative localization. Their portfolio also includes radiation therapy planning and dose calculation software, as well as radiological picture archiving and communication systems (PACS). Surgical tools such as single-use drill guides and vascular microcatheters are designed for neurosurgical and trauma applications, while invasive stereotactic head frames support radiosurgical interventions. Additional components include calibration adapters, alignment software, and reference markers for cranial procedures.
The company’s devices are classified under FDA regulations as Class I and Class II, with submissions recorded in the FDA’s 510(k) and UDI databases. Products are also subject to European medical device regulations under applicable class designations.
Catalogue
Search and filter all 132 devicesShowing 1-50 of 132
FDA recalls
FDA recall records list 47 recalls initiated by Brainlab AG, the earliest on 2006-06-02 and the most recent on 2025-02-10. By recorded status: 4 ongoing and 43 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 1
- 2019 3
- 2020 4
- 2021 2
- 2022 1
- 2023 2
- 2024 0
- 2025 1
- 2026 0
2025
- 10 Feb 2025 Z-1392-2025 Class II Ongoing Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
2023
- 2 Mar 2023 Z-1292-2023 Class II Ongoing Risk of mechanical instability due to potential manufacturing error of the device
- 14 Feb 2023 Z-1259-2023 Class II Ongoing Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Full distribution text
2022
- 25 Feb 2022 Z-0733-2022 Class II Ongoing The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Full distribution text
- 25 Feb 2022 Z-0733-2022 Class II Ongoing The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
2021
- 14 May 2021 Z-1846-2021 Class II Terminated Display of potential patient movement might be delayed to the user for high dose treatments.
Full distribution text
- 1 Mar 2021 Z-1185-2021 Class II Terminated 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 treatment despite potentially exceeding shift values.
Full distribution text
- 14 May 2021 Z-1846-2021 Class II Terminated Display of potential patient movement might be delayed to the user for high dose treatments.
2020
- 31 Aug 2020 Z-0056-2021 Class II Terminated Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Full distribution text
- 20 Aug 2020 Z-2925-2020 Class II Terminated Holding force of the Positioning Arm can be reduced by prolonged non-use.
- 16 Jul 2020 Z-2792-2020 Class II Terminated Incorrect manufacturer calibration
Full distribution text
- 16 Jul 2020 Z-2793-2020 Class II Terminated Incorrect manufacturer calibration
Full distribution text
- 31 Aug 2020 Z-0056-2021 Class II Terminated Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Show the 25 most recent of 47 recalls
2019
- 25 Sep 2019 Z-0176-2020 Class II Terminated 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/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances.
- 11 Mar 2019 Z-1205-2019 Class II Terminated 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), as is the default system setting.
Full distribution text
- 27 Feb 2019 Z-1082-2019 Class I Terminated 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 reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
Full distribution text
2018
- 14 Feb 2018 Z-1006-2018 Class II Terminated 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 Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
2017
- 16 Nov 2017 Z-0320-2018 Class II Terminated 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.
Full distribution text
- 3 Nov 2017 Z-0172-2018 Class II Terminated 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 treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
Full distribution text
- 28 Jul 2017 Z-0509-2018 Class II Terminated Risk of unintended motion while the AIRO system is in transport mode.
Full distribution text
- 16 Nov 2017 Z-0320-2018 Class II Terminated 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.
2016
- 27 Oct 2016 Z-0959-2017 Class II Terminated 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
Full distribution text
- 4 May 2016 Z-1929-2016 Class II Terminated Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Full distribution text
- 27 Oct 2016 Z-0959-2017 Class II Terminated 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
2015
- 5 Nov 2015 Z-0647-2016 Class II Terminated Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Full distribution text
- 5 Nov 2015 Z-0648-2016 Class II Terminated Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0
Full distribution text
- 21 Sep 2015 Z-0218-2016 Class II Terminated Potentially incorrectly displayed objects when actively deselecting a fused reference dataset.
Full distribution text
- 18 Aug 2015 Z-2795-2015 Class II Terminated 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.
Full distribution text
- 5 Aug 2015 Z-2440-2015 Class II Terminated ExacTrac 6.0 Patient Positioning System:
Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and
verification.
Full distribution text
- 8 May 2015 Z-0282-2016 Class II Terminated Instances of data sets not being accurately registered to the patient anatomy were observed.
- 5 Nov 2015 Z-0647-2016 Class II Terminated Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
FDA establishments
- Brainlab Ltd PETACH-TIKVA Central · IL FEI 3005225421
Frequently asked questions
How many devices does Brainlab AG have in the registry?
The registry currently lists 132 devices for Brainlab AG. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brainlab AG's devices?
Among its 50 most recently registered devices, Brainlab AG has devices listed in FDA 510(k) (50 devices).
What risk classes do Brainlab AG's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Brainlab AG's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Brainlab AG?
FDA recall records list 47 recalls initiated by Brainlab AG, the most recent initiated on 10 Feb 2025. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Brainlab AG in the registry?
The most recently registered devices listed for Brainlab AG include Automatic Registration, RT Elements (4.0), ENT EM and Z-TOUCH.
Which FDA establishments are linked to Brainlab AG?
1 FDA establishment is linked to Brainlab AG in the registry; they are listed on the company page.