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Medical robotics · recall

FDA Class II recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy.

S3 · 04 May 2016 · Brainlab

Record

CompanyBrainlab
IndustryMedical robotics
Type(s)recall
Date04 May 2016 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
ScaleExacTrac Vero is a Patient Positioning System for Radiation
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-1929-2016): Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)
DateSupporting source rowPublisherLink
04 May 2016 FDA Class II recall: ExacTrac Vero is a Patient Positioning System for Radiation therapy. openFDA enforcement openFDA enforcement

Medical robotics context

recall context

Brainlab industry position

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