CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report

ExacTrac Vero is a Patient Positioning System for Radiation therapy recalled

Brainlab is recalling ExacTrac Vero is a Patient Positioning System for Radiation therapy, distributed in Florida, New York, Ohio, Texas. The recall was initiated on 4 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPotentially 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

Quantity recalled27 Systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1929-2016
FDA event ID: 74265
Recalling firm: Brainlab, Feldkirchen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 4 May 2016
FDA classified: 8 Jun 2016
Reported: 15 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 May 2016	Recall initiated by company
8 Jun 2016	Classified by FDA	+35 days
15 Jun 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Where it was distributed

Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.

Florida New York Ohio Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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