FDA Device recall Z-1929-2016
ExacTrac Vero is a Patient Positioning System for Radiation therapy
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of ExacTrac Vero is a Patient Positioning System for Radiation therapy by Brainlab Ag, citing potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1929-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-04 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Brainlab Ag |
| Distribution | FL, NY, OH, TX |
Product
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Reason
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Identifiers
| code_info | Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not appli…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Brainlab Ag
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA Device · Class II · 2025-03-26 · Brainlab Ag - Cirq Arm System 2.0
FDA Device · Class II · 2023-04-05 · Brainlab Ag - Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F
FDA Device · Class II · 2023-03-22 · Brainlab Ag - ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
FDA Device · Class II · 2022-03-16 · Brainlab Ag - ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at…
FDA Device · Class II · 2021-06-16 · Brainlab Ag
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1929-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.