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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2017-11-03Z-0172-2018Class IITerminatedBrainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.Distribution: Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea28 unitsclearance family
2016-05-04Z-1929-2016Class IITerminatedPotentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5Distribution: Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.27 Systemsclearance family
Regulatory clearances
  • 510(k)K122451Substantially equivalent (SESE) · 2012-09-28clearance family

Predicate lineage

Cited as predicate by: K131965, K181789

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-02-20NAINo action indicatedBrainlab SE0
2025-02-20NAINo action indicatedBrainlab SE0
2016-02-25NAINo action indicatedBrainlab SE0
2016-02-25NAINo action indicatedBrainlab SE0
2013-06-21VAIVoluntary action indicatedBrainlab SE3
2013-06-21VAIVoluntary action indicatedBrainlab SE3
2011-05-27NAINo action indicatedBrainlab SE0
2011-05-27NAINo action indicatedBrainlab SE0
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