Z-0172-2018Class II

BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC...

Name: Z-0172-2018 BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC...
Creator: Brainlab AG
Published: 2017-11-03
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2017-11-03 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO... on 2017-11-03. FDA classified it as Class II and gives the reason as "Brainlab 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0172-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Posted: 2017-11-28
Terminated: 2020-12-14
Recalling firm: Brainlab, Inc.
Product: BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Brainlab 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm notified their consignees by email on November 3, 2017. "Instructions to customers what to do with the recalled product. For instructions for the user how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue, please also refer to the User Corrective Action section in the attached Field Safety Notice / Product Notification letter CAPA-20171011-001985: 1. After applying a couch shift always perform a verification image of the patient position before enabling the treatment beam. 2. Do not use the Virtual Isocenter function if a verification of the patient position in the treatment isocenter is not feasible. Please continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning in the Clinical User Guide ExacTrac Vero: Brainlab highly recommends performing an X-ray verification after each change to the couch/Robotics Position." For further questions, please call 1 (800) 784-7700.
Quantity in commerce: 28 units
Distribution: Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
Product codes and lots: Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field). UDI: 04056481132446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0172-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0172-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28

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)