FDA-Device2015-04-01Class II
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
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.
Sold states
Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
Affected count
24 systems (US); 36 systems (Foreign)
Manufactured in
Kapellenstrasse 12, Feldkirchen, Germany
Products
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2015Don't want to check this manually?
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