Brainlab AG
FDA Regulatory Profile
Brainlab AG appears in FDA public data with 39 recalls — including 2 Class I (most serious) —, 142 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1392-2025, Class II) was initiated on February 10, 2025. Its most recent 510(k) clearance was granted on October 16, 2025.
Summary
- Total Recalls
- 39 (2 Class I)
- 510(k) Clearances
- 142
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1392-2025 | Class II | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | February 10, 2025 |
| Z-1292-2023 | Class II | Cirq Arm System 2.0 | March 2, 2023 |
| Z-1259-2023 | Class II | Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-0 | February 14, 2023 |
| Z-0733-2022 | Class II | ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-0 | February 25, 2022 |
| Z-1846-2021 | Class II | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product | May 14, 2021 |
| Z-1185-2021 | Class II | ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). | March 1, 2021 |
| Z-0056-2021 | Class II | Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3. | August 31, 2020 |
| Z-2925-2020 | Class II | Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Ar | August 20, 2020 |
| Z-2792-2020 | Class II | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN | July 16, 2020 |
| Z-2793-2020 | Class II | BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 040 | July 16, 2020 |
| Z-0176-2020 | Class II | Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY | September 25, 2019 |
| Z-1205-2019 | Class II | RT Elements Software revisions of the RT Elements applications have a specific software version nu | March 11, 2019 |
| Z-1082-2019 | Class I | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Vers | February 27, 2019 |
| Z-1006-2018 | Class II | ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined poi | February 14, 2018 |
| Z-0320-2018 | Class II | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for | November 16, 2017 |
| Z-0172-2018 | Class II | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 | November 3, 2017 |
| Z-0509-2018 | Class II | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used fo | July 28, 2017 |
| Z-0959-2017 | Class II | Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / | October 27, 2016 |
| Z-1929-2016 | Class II | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | May 4, 2016 |
| Z-0648-2016 | Class II | RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, co | November 5, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | October 16, 2025 |
| K252562 | Spine & Trauma Navigation Instruments | September 12, 2025 |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | July 22, 2025 |
| K243142 | Cranial 4Pi Immobilization | June 23, 2025 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS | June 17, 2025 |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio | June 13, 2025 |
| K243810 | TraumaCad Neo (1.1) | June 4, 2025 |
| K242569 | Mixed Reality Spine Navigation | May 16, 2025 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial | January 28, 2025 |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | July 24, 2024 |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | May 23, 2024 |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | May 21, 2024 |
| K234047 | Automatic Registration | March 20, 2024 |
| K231498 | TraumaCad Neo | November 20, 2023 |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq A | September 9, 2023 |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | August 2, 2023 |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System | July 21, 2023 |
| K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Ma | July 14, 2023 |
| K231052 | ExacTrac Dynamic 1.1.2 | May 11, 2023 |
| K223734 | ENT EM | April 27, 2023 |