PlainRecalls
FDA Devices Moderate Class II Terminated

ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Reported: June 15, 2016 Initiated: May 4, 2016 #Z-1929-2016

Product Description

ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Reason for Recall

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

Details

Recalling Firm
Brainlab AG
Units Affected
27 Systems
Distribution
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Location
Feldkirchen, N/A

Frequently Asked Questions

What product was recalled?
ExacTrac Vero is a Patient Positioning System for Radiation therapy.. Recalled by Brainlab AG. Units affected: 27 Systems.
Why was this product recalled?
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Which agency issued this recall?
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1929-2016.