Z-2653-2014Class II

VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000...

Name: Z-2653-2014 VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000...
Creator: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Published: 2014-07-05
License: https://open.fda.gov/license/

Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work / initiated 2014-07-05 / Terminated / root cause: software

FDA source

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK began a recall of VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for... on 2014-07-05. FDA classified it as Class II and gives the reason as "Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed)...". 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-2653-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-05
Posted: 2014-09-16
Terminated: 2015-04-01
Recalling firm: Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Product: VERO Linear Accelerator System, Model Number MHI-TM2000; 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: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment
Root cause tag: software
FDA root cause: Software design
Action: A Preliminary Customer Information Letter (dated 7/4/14) was emailed to customers on 7/05/14 from Mitsubishi's sales and service representative in Germany. The letter informed customers of the potential safety issue associated with the VERO Linear Accelerator and the recommended actions to be taken. A formal URGENT FIELD SAFETY NOTICE Letter (dated 7/15/14) was emailed to customers on 8/07/14 from Mitsubishi's sales and service representative in Germany. The letter instructed customers to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions to be taken.
Quantity in commerce: 3 units in use in the US
Distribution: Distributed in the states of NY, FL, and TX.
Product codes and lots: Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2653-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2653-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-24	2014-09-16

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)