Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ExacTrac 6.x. is software used to place patients at an Recalled by Brainlab AG Due to ExacTrac 6.x Patient Positioning System: Potentially incorrect patient...
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.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Quantity: 25 systems (US only); 53 systems (Foreign)
Why Was This Recalled?
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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