Manufacturer
39 recalls in our database name Brainlab AG as the manufacturing or recalling firm.
Of the 39 recalls from Brainlab AG we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (8%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
Brainlab AG is recalling Cirq Arm System 2.0 devices due to potential mechanical instability from manufacturing errors. Users should discontinue use and contact the manufacturer.
Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.
ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.
Brainlab's ExacTrac Dynamic radiotherapy positioning software may delay display of patient movement during high-dose treatments, risking treatment precision errors. 22 systems affected across 11 U.S. states.
Brainlab AG is recalling ExacTrac Dynamic radiation therapy systems due to a software error that may allow treatment despite exceeding position tolerances.
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.
Brainlab AG is recalling 21 Cirq Arm Systems because prolonged non-use can reduce the holding force of the positioning arm.
Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.
Brainlab AG is recalling 18 Curve navigation stations due to incorrect manufacturer calibration. The devices were distributed in the US and internationally.
Brainlab is recalling Patient Data Manager software versions 2.1.1 through 2.5.1 because segmentation shifts may not be reflected in DICOM exports.
Brainlab AG is recalling specific versions of RT Elements software due to a potential for incorrect dose distribution calculations when using the Pencil Beam algorithm on the GPU.
Brainlab AG is recalling Spine & Trauma 3D Navigation 1.0 software because it may display fixed image planes instead of the desired inline view, potentially preventing surgeons from determining instrument position.
Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.
Brainlab AG is recalling 102 AIRO Mobile CT Systems due to a risk of unintended motion while the system is in transport mode.
Brainlab AG is recalling DrapeLink Adapters because a supplier error caused some units to not meet specifications.
Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.
Brainlab AG is recalling specific femoral and tibial cutting block adapter bases because they may contain incorrect material, making them unsuitable for reprocessing.
Brainlab AG is recalling 27 ExacTrac Vero 3.5 systems due to potentially incorrect positioning when using Implanted Marker Detection.
Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.
Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.
Brainlab AG is recalling Brain Metastases 1.0.0 software because large objects may display cropped during import.
Brainlab AG is recalling 12 Image Guided Surgery systems in the US and Australia because data sets were not accurately registered to patient anatomy.
Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.
Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.