Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ExacTrac versions 6.x patient positioning systems are used to position Recalled by Brainlab AG Due to The ExacTrac 6.x Patient Positioning System may incorrectly...
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 versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Quantity: 24 systems (US); 36 systems (Foreign)
Why Was This Recalled?
The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
Where Was This Sold?
Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
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