Munich, N/A, Germany
Brainlab AG recalls
15 recalls recorded since 2018, most recently on 10 February 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)4
Terminated or completed11
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 10 February 2025
- Reason
- Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1392-2025
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Ongoing Class II Medical devices
- Recall started
- 2 March 2023
- Reason
- Risk of mechanical instability due to potential manufacturing error of the device
- Distribution
- Texas
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1292-2023
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
- Distribution
- US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1259-2023
- Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Ongoing Class II Medical devices
- Recall started
- 25 February 2022
- Reason
- The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
- Distribution
- Distribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY, NC, OK, OR, PA, TX, VA, and WA. There was no government or military distribution. Foreign distribution was made to Australia, Austria, Bahrain, Belgium, China, Denmark, France, Germany, Hong Kong, India, Ireland, Israel,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0733-2022
- ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Position
Terminated Class II Medical devices
- Recall started
- 14 May 2021
- Terminated
- 20 March 2023
- Reason
- Display of potential patient movement might be delayed to the user for high dose treatments.
- Distribution
- US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1846-2021
- ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator f
Terminated Class II Medical devices
- Recall started
- 1 March 2021
- Terminated
- 20 March 2023
- 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 treatment despite potentially exceeding shift values.
- Distribution
- USA: (CA, NJ, AZ, AR, NY, IN, OR, NC), Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Italy, Slovakia, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1185-2021
- ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Terminated Class II Medical devices
- Recall started
- 31 August 2020
- Terminated
- 17 February 2021
- Reason
- Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerla
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0056-2021
- Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally i
Terminated Class II Medical devices
- Recall started
- 20 August 2020
- Terminated
- 13 May 2021
- Reason
- Holding force of the Positioning Arm can be reduced by prolonged non-use.
- Distribution
- USA: DC, OH, IL OUS: Bulgaria; France; Germany; United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2925-2020
- 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)
Terminated Class II Medical devices
- Recall started
- 16 July 2020
- Terminated
- 27 July 2021
- Reason
- Incorrect manufacturer calibration
- Distribution
- USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2793-2020, Z-2792-2020
- BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
- BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Terminated Class II Medical devices
- Recall started
- 25 September 2019
- Terminated
- 25 March 2024
- 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/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.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0176-2020
- Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PAT
Terminated Class II Medical devices
- Recall started
- 11 March 2019
- Terminated
- 12 May 2021
- 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), as is the default system setting.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KY, LA, MA, MD, MS, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, & WV. Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, El Salvador, Finland, France, Germany, Hong Kon
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1205-2019
- RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine
Terminated Class I Medical devices
- Recall started
- 27 February 2019
- Terminated
- 10 July 2019
- 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 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.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1082-2019
- Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localizati
Terminated Class II Medical devices
- Recall started
- 14 February 2018
- Terminated
- 17 May 2021
- 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 Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1006-2018
- 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 medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order
Terminated Class II Medical devices
- Recall started
- 16 November 2017
- Terminated
- 24 August 2020
- 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.
- Distribution
- Distributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0320-2018
- Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Terminated Class II Medical devices
- Recall started
- 28 July 2017
- Terminated
- 25 July 2018
- Reason
- Risk of unintended motion while the AIRO system is in transport mode.
- Distribution
- Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV; and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0509-2018
- AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patien
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.