FDA-Device2016-06-15Class II

ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Brainlab AG
Hazard

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

Sold states
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Affected count
27 Systems
Manufactured in
Kapellenstr. 12, N/A, Feldkirchen, N/A, Germany
Products
ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1929-2016

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