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Brainlab AG recalls ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Recalled June 15, 2016 · FDA recall Z-1929-2016 · Brainlab AG
Hazard
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 · FDA Class II
Units
27 Systems
Sold at
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Description
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Product
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →