Z-1931-2013Class II

MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade...

Name: Z-1931-2013 MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade...
Creator: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Published: 2013-06-21
License: https://open.fda.gov/license/

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work / initiated 2013-06-21 / 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 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical... on 2013-06-21. FDA classified it as Class II and gives the reason as "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...". 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-1931-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-21
Posted: 2013-08-08
Terminated: 2017-03-23
Recalling firm: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Product: 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 code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm, Mitsubishi Heavy Industries, Ltd. (MHI), sent an "URGENT FIELD SAFETY NOTICE" letter dated June 21, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If any minor failure occurs, please always press [ALARM RESET] button on operator console first; and if [EXIT] button is clicked after a minor failure occurs, please click [YES] on the pop up dialog to finish treatment completely. MHI is developing a correction for this issue. Tentatively planned availability date: End of October 2013. The correction will be free of charge and a MHI Customer Service representative will contact affected customers to schedule its installation as the correction becomes available. If you need any further information or support concerning this issue, please feel free to contact our Customer Service representative: VERO GmbH, Kapellenstrasse 12, 8566 Feldkirchen Germany, at +49-89-99-1568-44 or email: [email protected].
Quantity in commerce: 14 (2 in US)
Distribution: Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
Product codes and lots: Serial Numbers #s 201902 and 203901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1931-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1931-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08

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)