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  Class 2 Device Recall BRAINLAB EXACTRAC VERO see related information
Date Initiated by Firm November 03, 2017
Create Date November 28, 2017
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-0172-2018
Recall Event ID 78488
510(K)Number K122451  
Product Classification Accelerator, linear, medical - Product Code IYE
Product BRAINLAB EXACTRAC VERO, Model/Catalog Numbers:
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.
Code Information 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
Recalling Firm/
Brainlab AG
Olof-Palme-Strasse 9
Munich Germany
Manufacturer 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.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = BRAINLAB AG