Home / Recalls / MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK / Z-1574-2015

Z-1574-2015 Class II Terminated

Recalled by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK — HIROSHIMA, N/A

Recall Details

Product Type
Devices
Report Date
May 13, 2015
Initiation Date
April 17, 2015
Termination Date
April 11, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 units total

Product Description

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

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.

Distribution Pattern

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

Code Information

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

Other recalls by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

  • Z-1308-2016 Class II — VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accel (March 7, 2016)
  • Z-1244-2016 Class II — MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intende (December 15, 2015)
  • Z-0821-2015 Class II — VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-140 (December 2, 2014)
  • Z-2653-2014 Class II — VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical L (July 5, 2014)
  • Z-1931-2013 Class II — MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earl (June 21, 2013)