Brainlab AG recalls
Every recall we track for Brainlab AG — 17 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Brainlab AG peaked in 2020 (4); 17 since 2017.
All FDA recall records for Brainlab AG since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 2 | 0 | 1 | 3 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 1 | 2 | 0 | 3 |
| 2020 | 0 | 1 | 3 | 0 | 4 |
| 2021 | 0 | 2 | 0 | 0 | 2 |
| 2022 | 0 | 1 | 0 | 0 | 1 |
| 2023 | 0 | 1 | 1 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Brainlab AG recalls
What to do if you have a recalled Brainlab AG product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Brainlab AG recalls
16 shown- Lower riskMedical device
Brainlab AG recalls Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Brainlab recalls software versions 3.1.0-3.2.1 due to risk of merging unrelated patient records into one without user notification. Affected users should contact Brainlab for details.
BrainlabFeb 10, 2025 - Use cautionMedical device
Brainlab AG recalls Cirq Arm System 2.0
Brainlab recalls Cirq Arm System 2.0 devices due to potential manufacturing errors causing mechanical instability. Affected units include all serial numbers and lot numbers.
BrainlabMar 2, 2023 - Lower riskMedical device
Brainlab AG recalls Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Brainlab recalls ExacTrac Dynamic software models 20910-01E and 20910-01F (versions 1.1.0-1.1.1) due to potential DIBH functionality issues in radiation therapy workflows.
BrainlabFeb 14, 2023 - Use cautionMedical device
Brainlab AG recalls ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and
Brainlab recalls ExacTrac Dynamic software versions 1.0.0-1.0.3 for potential incorrect yaw angle during CBCT positioning with Varian LINACs. Affected units include specific model numbers and GTIN.
BrainlabFeb 25, 2022 - Use cautionMedical device
Brainlab AG recalls ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to
Brainlab recalls ExacTrac Dynamic software version 1.0.2 for potential delayed patient movement display during high-dose radiation treatments. Affected units may require software update to prevent safety risks.
BrainlabMay 14, 2021 - Use cautionMedical device
Brainlab AG recalls ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Brainlab recalls ExacTrac Dynamic radiation therapy systems with software versions 1.0.0-1.0.2 due to potential unsafe patient positioning during treatment. Affected units may allow treatment to proceed when patient is out of safe range.
BrainlabMar 1, 2021 - Lower riskMedical device
Brainlab AG recalls Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x -
Brainlab recalls ultrasound navigation software versions 1.0 and 3.0.x/3.1.x due to inability to modify probe image width. This may affect surgical precision during minimally invasive procedures. Affected units include specific model numbers and subscription packages.
BrainlabAug 31, 2020 - Lower riskMedical device
Brainlab AG recalls 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
Brainlab recalls Cirq Arm System models SBS 1.3.2 and SBS 1.4 due to reduced holding force from prolonged non-use. Affected units have specific serial numbers and article numbers.
BrainlabAug 20, 2020 - Use cautionMedical device
Brainlab AG recalls BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Brainlab recalls Kick 2 navigation stations with incorrect calibration that may cause inaccurate measurements during surgery. Affected units have specific model and serial numbers listed in the recall notice.
BrainlabJul 16, 2020 - Lower riskMedical device
Brainlab AG recalls Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT
Brainlab recalls Patient Data Manager software versions 2.1.1-2.5.1 used with iPlan CMF/Cranial/ENT/Spine 3.0.5-3.0.6 due to potential segmentation errors when exporting to DICOM.
BrainlabSep 25, 2019 - Lower riskMedical device
Brainlab AG recalls RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically
Brainlab recalls specific RT Elements software versions (1.0.0 and 1.5.0) for cranial, spine, and multiple brain mets SRS applications due to potential incorrect dose distribution calculations when using Pencil Beam algorithm on GPU.
BrainlabMar 11, 2019 - Use cautionMedical device
Brainlab AG recalls Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended
Brainlab recalls Spine & Trauma 3D Navigation 1.0 software due to potential navigation errors during surgery. Affected units may show incorrect instrument positions, risking surgical errors. Contact for remedy.
BrainlabFeb 27, 2019 - Use cautionMedical device
Brainlab AG recalls ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the
Brainlab recalls ExacTrac software versions 6.0-6.5 for possible misinterpretation of beam authorization when used with certain radiation therapy systems, requiring users to follow specific safety steps.
BrainlabFeb 14, 2018 - UnratedMedical device
Brainlab AG recalls Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision
Brainlab recalls specific DrapeLink Adapters for spine/trauma 3D systems due to manufacturing error. Affected units have unique serial numbers and model numbers. No remedy stated in recall notice.
BrainlabNov 16, 2017 - Use cautionMedical device
Brainlab AG recalls BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW
Brainlab recalls ExacTrac Vero 3.5 models due to potential treatment position errors. Affected units may not move to planned positions, risking inaccurate radiation therapy. Contact Brainlab for updates.
BrainlabNov 3, 2017 - Use cautionMedical device
Brainlab AG recalls AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed
Brainlab recalls AIRO Mobile CT System (MobiCT-32) due to risk of unintended motion in transport mode. All units released since April 2014 with specific serial numbers are affected.
BrainlabJul 28, 2017
Brainlab AG recall questions
How many recalls has Brainlab AG had?
17 recalls from Brainlab AG are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Brainlab AG recall?
Brainlab AG recalls Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1, dated Feb 10, 2025. Every Brainlab AG recall is listed on this page, newest first.
Why are Brainlab AG products recalled?
The most common reasons on record: Incorrect manufacturer calibration (2).
What should I do if I have a recalled Brainlab AG product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Brainlab AG recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.