MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: Medical Device Recall in 2016 - (Recall #: Z-1308-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

VERO MHI-TM2000 Linear Accelerator System --- 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: March 7, 2016

Date Posted: April 6, 2016

Recall Number: Z-1308-2016

Event ID: 73436

Reason for Recall:

In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.

Status: Terminated

Product Quantity: 25 Worldwide, US: 4 units

Code Information:

Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924

Distribution Pattern:

Nationwide Distribution including New York, Texas, Florida, and Ohio

Voluntary or Mandated:

Voluntary: Firm initiated