MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: Medical Device Recall in 2014 - (Recall #: Z-2653-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Product Classification:

Class II

Date Initiated: July 5, 2014

Date Posted: September 24, 2014

Recall Number: Z-2653-2014

Event ID: 68909

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 units in use in the US

Code Information:

Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919

Distribution Pattern:

Distributed in the states of NY, FL, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated