Brainlab recalls
4 official recalls and safety alerts involving Brainlab since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Brainlab or the relevant agency.
- 2025-03-26
USBrainlab AG recalls Origin 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.
- 2023-04-05
- US
Brainlab AG recalls Cirq Arm System 2.0
Risk of mechanical instability due to potential manufacturing error of the device
- 2023-03-22
- US
Brainlab AG recalls Brainlab 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
FDA · DeviceBrainlab AGUS Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN,…Official notice → - 2022-03-16
- US
Brainlab AG recalls ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST;…
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
FDA · DeviceBrainlab AGDistribution was made to AZ, AR, CA, CO, FL, GA, IN, KY, MD, MS, MO, NJ, NY,…Official notice →