Brainlab AG recalls ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy pro…

Recall date

February 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1316-2015

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..