Brand
Brainlab AG
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Brainlab AG and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-26FDA-DeviceClass IIOrigin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
- 2023-04-05FDA-DeviceClass IICirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device
- 2023-03-22FDA-DeviceClass IIBrainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
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