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Brainlab AG recalls ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy proc
Recalled April 1, 2015 · FDA recall Z-1316-2015 · Brainlab AG
Hazard
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. · FDA Class II
Units
24 systems (US); 36 systems (Foreign)
Sold at
Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
Description
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.
Product
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →