MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: Medical Device Recall in 2013 - (Recall #: Z-1931-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 21, 2013

Date Posted: August 14, 2013

Recall Number: Z-1931-2013

Event ID: 65786

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.

Status: Terminated

Product Quantity: 14 (2 in US)

Code Information:

Serial Numbers #s 201902 and 203901

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated