Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BrainLAB Image Guided Surgery (IGS) System Recalled by Brainlab AG Due to Instances of data sets not being accurately registered...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Brainlab AG directly.
Affected Products
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.
Quantity: 12 systems total (10 in U.S., 2 in Australia)
Why Was This Recalled?
Instances of data sets not being accurately registered to the patient anatomy were observed.
Where Was This Sold?
Distributed in the US and Australia.
About Brainlab AG
Brainlab AG has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report