Every recall we track for Brainlab AG — 17 in all — plus the complaints and injury reports the public filed about them.
Brainlab recalls software versions 3.1.0-3.2.1 due to risk of merging unrelated patient records into one without user notification. Affected users should contact Brainlab for details.
Brainlab recalls Cirq Arm System 2.0 devices due to potential manufacturing errors causing mechanical instability. Affected units include all serial numbers and lot numbers.
Brainlab recalls ExacTrac Dynamic software models 20910-01E and 20910-01F (versions 1.1.0-1.1.1) due to potential DIBH functionality issues in radiation therapy workflows.
Brainlab recalls ExacTrac Dynamic software versions 1.0.0-1.0.3 for potential incorrect yaw angle during CBCT positioning with Varian LINACs. Affected units include specific model numbers and GTIN.
Brainlab recalls ExacTrac Dynamic software version 1.0.2 for potential delayed patient movement display during high-dose radiation treatments. Affected units may require software update to prevent safety risks.
Brainlab recalls ExacTrac Dynamic radiation therapy systems with software versions 1.0.0-1.0.2 due to potential unsafe patient positioning during treatment. Affected units may allow treatment to proceed when patient is out of safe range.
Brainlab recalls ultrasound navigation software versions 1.0 and 3.0.x/3.1.x due to inability to modify probe image width. This may affect surgical precision during minimally invasive procedures. Affected units include specific model numbers and subscription packages.
Brainlab recalls Cirq Arm System models SBS 1.3.2 and SBS 1.4 due to reduced holding force from prolonged non-use. Affected units have specific serial numbers and article numbers.
Brainlab recalls Curve navigation stations with specific model numbers due to incorrect calibration, which could lead to inaccurate measurements during medical procedures.
Brainlab recalls Kick 2 navigation stations with incorrect calibration that may cause inaccurate measurements during surgery. Affected units have specific model and serial numbers listed in the recall notice.
Brainlab recalls Patient Data Manager software versions 2.1.1-2.5.1 used with iPlan CMF/Cranial/ENT/Spine 3.0.5-3.0.6 due to potential segmentation errors when exporting to DICOM.
Brainlab recalls specific RT Elements software versions (1.0.0 and 1.5.0) for cranial, spine, and multiple brain mets SRS applications due to potential incorrect dose distribution calculations when using Pencil Beam algorithm on GPU.
Brainlab recalls Spine & Trauma 3D Navigation 1.0 software due to potential navigation errors during surgery. Affected units may show incorrect instrument positions, risking surgical errors. Contact for remedy.
Brainlab recalls ExacTrac software versions 6.0-6.5 for possible misinterpretation of beam authorization when used with certain radiation therapy systems, requiring users to follow specific safety steps.
Brainlab recalls specific DrapeLink Adapters for spine/trauma 3D systems due to manufacturing error. Affected units have unique serial numbers and model numbers. No remedy stated in recall notice.
Brainlab recalls ExacTrac Vero 3.5 models due to potential treatment position errors. Affected units may not move to planned positions, risking inaccurate radiation therapy. Contact Brainlab for updates.
