FDAApril 22, 2013device
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex navigation procedure that may cause an inaccurate display of instruments by the navigation system compared to the actual patient anatomy.
What to do
FDA enforcement status: Terminated
Brands named
brainlab agbrainlab
UPCs
220351039110042203510395300122035103977001220351039820022203510398700122035103988001220351045660012204010367500622040103687009220401037100012204010394200822040103974011
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOrigin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.12025-02-10
- FDACirq Arm System 2.02023-03-02
- FDABrainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.2023-02-14
- FDAExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.2022-02-25
- FDAExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patie...2021-05-14
- FDAExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).2021-03-01
- FDAUltrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery.2020-08-31
- FDACirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)2020-08-20
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