Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ExacTrac 6.0.x Patient Positioning System Recalled by Brainlab AG Due to ExacTrac 6.0 Patient Positioning System: Display of potentially...
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
ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Quantity: 361 systems
Why Was This Recalled?
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification.
Where Was This Sold?
This product was distributed to 32 states: AL, AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI
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