Reported Jun 15, 2016 · Terminated
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstr. 12 · Feldkirchen, N/A · N/A
Is this the product you have?
- ExacTrac Vero is a Patient Positioning System for Radiation therapy.
- Lot codes and dates
- Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version
- Model/catalogue numbers20892 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
- Amount recalled
- 27 Systems
Where it was sold
Why it was recalled
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
This product could cause temporary or reversible health problems — stop using it.
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