Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brainlab Recalled by Brainlab AG Due to The "fluoro match registration" function of the Navigation...
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, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Quantity: 133 units
Why Was This Recalled?
The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX, WI
About Brainlab AG
Brainlab AG has 39 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report