Brainlab Ultrasound Navigation Software Recalled for Image Width Limitation
Brainlab AG is recalling Ultrasound Navigation Software 1.0 and related integration software because the system does not support modifying the probe's image width.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional software limitation (inability to modify image width) rather than a direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Brainlab AG is recalling Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x. The recall involves 271 units of software intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
The recall was initiated because the software does not support the modification of the probe's image width. This limitation affects the functionality of the ultrasound navigation system during surgical procedures.
The affected software was distributed worldwide, including in the United States and numerous international countries. Users of this software should contact Brainlab AG for further instructions regarding the recall and potential remediation.
The recalled product
- Product
- 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 invasive surgery.
- Manufacturer
- Brainlab AG
- Hazard
- Affected units
- 271
Distribution
Related recalls
Same manufacturer · Brainlab AG
See all →- HighMedical Device Software May Merge Patient Records Without Notification
FDA (Devices) · 2025-03-26
- HighSurgical navigation system recalled for potential mechanical instability
FDA (Devices) · 2023-04-05
- HighRadiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold
FDA (Devices) · 2023-03-22
- HighExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning
FDA (Devices) · 2022-03-16
- HighRadiotherapy positioning software may delay patient movement display
FDA (Devices) · 2021-06-16
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- SevereBrainlab Spine & Trauma 3D Navigation Software Recall for Display Error
FDA (Devices) · 2019-04-24
- HighBrainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error
FDA (Devices) · 2014-08-20
- SevereBrainlab Cranial Navigation System Recalled for Potential Software Inaccuracy
FDA (Devices) · 2016-01-27
- HighBrainlab Spine & Trauma 3D 2.0 Navigation Software Recalled for Registration Defect
FDA (Devices) · 2014-04-23
- HighBrainlab IGS System Recalled for Inaccurate Patient Anatomy Registration
FDA (Devices) · 2015-11-25
- ModerateBrainlab Brain Metastases Software Recall for Image Display Errors
FDA (Devices) · 2016-01-20