FDAFDA · Food and drugs·Recall number Z-1929-2016
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Published June 15, 2016 · Recall initiated: May 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Brainlab AG
- Distributor
- Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
- Lot
- Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: 20892 EXACTRAC VERO SOFTWARE 3.5 20892A EXACTRAC VERO SOFTWARE 3.5.1 20892B EXACTRAC VERO SOFTWARE 3.5.2 20892C EXACTRAC VERO SOFTWARE 3.5.3 20893 VERO INFRARED POSITIONING/MONITORING SW 46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1 46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC 46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46228 EXACTRAC VERO 3.5 ROW 46238 EXACTRAC VERO 3.5 JAPAN
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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