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Brainlab AG FDA Recalls
6 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1Class IIFeb 10, 2025Under certain circumstances, it can occur that patient recor |
| Cirq Arm System 2.0Class IIMar 2, 2023Risk of mechanical instability due to potential manufacturin |
| Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.Class IIFeb 14, 2023Deep Inspiration Breath Hold (DIBH) functionality may not wo |
| ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning Class IIFeb 25, 2022The yaw angle may be incorrect for CBCT positioning workflow |
| ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to pClass IIMay 14, 2021Display of potential patient movement might be delayed to th |
| ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).Class IIMar 1, 2021In case of a failed automatic marker detection, a software e |