MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: Medical Device Recall in 2015 - (Recall #: Z-1574-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

Product Classification:

Class II

Date Initiated: April 17, 2015

Date Posted: May 13, 2015

Recall Number: Z-1574-2015

Event ID: 70638

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11 units total

Code Information:

Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924

Distribution Pattern:

Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.

Voluntary or Mandated:

Voluntary: Firm initiated