Mhi-TM2000 Linear Accelerator System Vero Imavis

• Terminated Z-1585-2018 FDA Class II ·initiated 8 Dec 2017

Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.

• Terminated Z-1308-2016 FDA Class II ·initiated 7 Mar 2016

In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.

• Terminated Z-1244-2016 FDA Class II ·initiated 15 Dec 2015

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.

• Terminated Z-1574-2015 FDA Class II ·initiated 17 Apr 2015

The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.

• Terminated Z-0821-2015 FDA Class II ·initiated 2 Dec 2014

Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port

• Terminated Z-2653-2014 FDA Class II ·initiated 5 Jul 2014

Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment

• Terminated Z-1931-2013 FDA Class II ·initiated 21 Jun 2013

Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.