Home / Recalls / MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK / Z-1931-2013

Z-1931-2013 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
August 14, 2013
Initiation Date
June 21, 2013
Termination Date
March 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 (2 in US)

Product Description

MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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

Reason for Recall

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.

Distribution Pattern

Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.

Code Information

Serial Numbers #s 201902 and 203901

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-1574-2015 Class II — MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) (April 17, 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)