Z-1574-2015Class II

MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)

Name: Z-1574-2015 MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Creator: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Published: 2015-04-17
License: https://open.fda.gov/license/

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work / initiated 2015-04-17 / Terminated / root cause: software

FDA source

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK began a recall of MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) on 2015-04-17. FDA classified it as Class II and gives the reason as "The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered...". 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-1574-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-17
Posted: 2015-05-01
Terminated: 2017-04-11
Recalling firm: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Product: MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: MITSUBISHI HEAVY INDUSTRIES, LTD. has issued a Safety Alert for the MHI-TM2000 Linear Accelerator System dated April 10, 2015, due to a software issue. Customers were advised not to deliver therapeutic X-ray if popup warning message show is displayed during treatment. Instructions were provided if therapeutic radiation is delivered during popup warning. Customers with questions should contact the Customer Service Representative by calling 1-800-597-5911, Monday through Friday or email: [email protected]. **CAPA** Correction software for this issue has a tentative availability date of June 2015. Estimated software update completion date would be end of October 2015.
Quantity in commerce: 11 units total
Distribution: Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Product codes and lots: Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1574-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1574-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01

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)