Z-1244-2016Class II

MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of...

Name: Z-1244-2016 MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of...
Creator: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Published: 2015-12-15
License: https://open.fda.gov/license/

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work / initiated 2015-12-15 / Terminated / root cause: software

FDA source

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK began a recall of MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body... on 2015-12-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1244-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-15
Posted: 2016-03-24
Terminated: 2017-04-20
Recalling firm: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Product: 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 code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: 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" if all the following conditions are met: (1) At least one patient has been treated on the day; (2) A major error occurs when VeroTM/MHI-TM2000 is operated in a mode, other than Clinical Mode, which means Daily Check Mode or Maintenance Mode. (3) The major error is NOT associated with a function that uses therapeutic/ MV radiation parameters, such as an error in Isocenter Check function, etc. Note 1: If the major error is associated with a function that uses therapeutic/MV radiation parameters, the problem that treatment completion status is changed will never occur. The Operator Console changes the treatment completion status in the course of processing the major error. Note 2: Although treatment completion status is changed to "Untreated", its delivered dose result has been correctly saved into R&V System. It has not been lost. Advice on Actions by Customer/Users: 1. Please make sure to perform the operations as described below in case a major error occurred in a mode other than Clinical Mode. (1) Cancel the error. (2) Click [Clinical] button on the left of Operator Console screen. (3) Verify, on R&V System screen, that treatment completion status of the patients who were treated on the day are all correct. The treatment completion status is indicated in different colors as follows depending on the status: Untreated: BLUE, Completed: GRAY, Discontinued: RED. Customers requiring support concerning this issue, please contact the Customer Service Representative: 1-800-597-5911 (Mon - Fri) or via email [email protected]. If any other problem is detected, please stop operation and contact the Customer Service representative.
Quantity in commerce: 25 devices (4 domestically in U.S.A. and 21 internationally)
Distribution: Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1244-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1244-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)