MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: Medical Device Recall in 2016 - (Recall #: Z-1244-2016)

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:

MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.

Product Classification:

Class II

Date Initiated: December 15, 2015

Date Posted: March 30, 2016

Recall Number: Z-1244-2016

Event ID: 72991

Reason for Recall:

Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.

Status: Terminated

Product Quantity: 25 devices (4 domestically in U.S.A. and 21 internationally)

Code Information:

Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.

Distribution Pattern:

Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.

Voluntary or Mandated:

Voluntary: Firm initiated