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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74265

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 04, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Brainlab AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Z-1929-2016
Recall number
Z-1929-2016
Initiated
May 04, 2016
Classification
Class II
Status
Terminated
Recalling firm
Brainlab AG
Quantity
27 Systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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