Brainlab AG recalls ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Recall date

May 4, 2016

Source

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

Recall number

Z-1929-2016

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.

Why it was recalled

Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

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 Vero is a Patient Positioning System for Radiation therapy.