Z-1929-2016Class II

ExacTrac Vero is a Patient Positioning System for Radiation therapy

Name: Z-1929-2016 ExacTrac Vero is a Patient Positioning System for Radiation therapy
Creator: Brainlab AG
Published: 2016-05-04
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2016-05-04 / Terminated / root cause: design

FDA source

Brainlab AG began a recall of ExacTrac Vero is a Patient Positioning System for Radiation therapy on 2016-05-04. FDA classified it as Class II and gives the reason as "Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1929-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-06-08
Terminated: 2017-07-24
Recalling firm: Brainlab, Inc.
Product: ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Root cause tag: design
FDA root cause: Device Design
Action: A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION was sent to customers on May 4, 2016 and distributed via email. An active reply by the consignees will be followed, if necessary via further different communication media. As of now for new installations - the Product Notification letter is handed over to the customer during installation (before clinical use) by the according Brainlab Service representative, - a signature is required by the customer that the contained User Corrective Action will be implemented before clinical use by the facility (to be adhered to by the users). Brainlab Instructions and actions required to be performed by the customer are described below. 1. For Positioning and Verification, carefully review plausibility of implant marker fusions resulting in rotation angles of more than 10. If in doubt consider the following options before proceeding: - Deselect one or several markers defined in the CT data set, if you suspect these markers to have migrated - Apply bony fusion instead of marker based fusion - Apply ConeBeam CT correction and verification instead of marker based fusion - Acquire a new CT scan and repeat treatment planning and definition of implanted marker positions based on the new CT data. For further details regarding the suggested proceedings, please consult the according Clinical User Guide. 2. For Dynamic Tracking continue to follow the instructions of the Clinical User Guide regarding the review of the correlation model based on implanted marker detections. Specifically: - Examine the correctness of localization of markers and targets in the X-ray sequence. - Verify the consistency of the Target Detection Curve and/or Correlation Model Curve. Irregularities of the curves are an indication for incorrect implanted marker detection. In this case please consider the options described in 1. before proceeding. If the customers require further clarification, they should contact their local Brainlab Customer
Quantity in commerce: 27 Systems
Distribution: Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1929-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1929-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-08

Product code IYE

K122451Class IIExactrac VeroBrainlab AG / cleared 2012-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)